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Combined phacoemulsification–viscosynechialysis–trabeculotomy vs phacotrabeculectomy in uncontrolled primary angle-closure glaucoma with cataract
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ARTICLE
Combined phacoemulsification–viscosynechialysis– trabeculotomy vs phacotrabeculectomy in uncontrolled primary angle-closure glaucoma with cataract Ahmed S. Elwehidy, MD, PhD, Nader H.L. Bayoumi, MD, PhD, FRCS(G), Amani E. Badawi, MD, PhD, Sherein M. Hagras, MD, PhD, Rania Kamel, MD, PhD
Purpose: To compare the effect on intraocular pressure (IOP) of phacoemulsification combined with viscosynechialysis and trabeculotomy with that of phacoemulsification combined with trabeculectomy in eyes with primary angle-closure glaucoma (PACG) and visually significant cataract.
Setting: Mansoura Ophthalmic Center, Mansoura University, Egypt.
Design: Prospective case series. Methods: This prospective randomized study included patients with uncontrolled PACG and visually significant cataract presenting between 2012 and 2017. The eyes were randomized to phacoemulsification combined with viscosynechialysis and trabeculotomy (phaco–viscosynechialysis group) or phacoemulsification combined with trabeculectomy (phacotrabeculectomy group). Success (true and qualified) (IOP <18 mm Hg without sight-threatening complications) was studied 24 months postoperatively.
G
laucoma is a type of optic neuropathy characterized by optic nerve damage (cupping) associated with corresponding visual field changes. Intraocular pressure (IOP) can be a significant factor in the development of this condition.1 Glaucoma is classified etiologically into primary and secondary entities, each of which is further classified gonioscopically into open angle and narrow (closed) angle based on the configuration of the anterior chamber angle.2 Narrow-angle glaucoma represents 26% of glaucoma cases worldwide3 and is more prevalent in the Middle East and
Intraoperative complications were noted. The primary outcome measure was the IOP before and after surgery.
Results: The study comprised 59 eyes of 59 patients with a mean age of 59.8 years G 6.8 (SD) in the phaco–viscosynechialysis group (30 eyes) and 60.3 G 6.3 years in the phacotrabeculectomy group (29 eyes) (P Z .704). The mean preoperative IOP was 28.7 G 2.14 mm Hg in the phaco–viscosynechialysis group and 28.5 G 2.11 mm Hg in the phacotrabeculectomy group; the mean at 24 months was 14.5 G 2.8 mm Hg and 17.3 G 2.2 mm Hg, respectively (P < .001). The total success rate at 24 months was 90% and 83%, respectively. Conclusion: Although both techniques were relatively safe and effective in reducing IOP for at least 2 years in eyes with PACG, combined phacoemulsification–viscosynechialysis–trabeculotomy gave better outcomes. J Cataract Refract Surg 2019; 45:1738–1745 Q 2019 ASCRS and ESCRS
Southeast Asia.4 Foster et al.5 recently classified primary angle closure (PAC) as PAC suspect (with appositional narrow angle), PAC (evidence of previous iridocorneal contact without affecting the optic nerve), and PAC glaucoma (with peripheral anterior synechiae [PAS] with optic nerve cupping associated with corresponding visual field defects), known classically as primary angle-closure glaucoma (PACG). Primary angle-closure suspect cases can be managed with peripheral laser iridotomy6,7 to relieve the pupil block or with argon laser peripheral iridoplasty.8 Eyes with PACG require more elaborate treatment because
Submitted: March 26, 2019 | Final revision submitted: July 25, 2019 | Accepted: July 29, 2019 From the Faculty of Medicine (Elwehidy, Badawi, Hagras, Kamel), Mansoura University, and Faculty of Medicine (Bayoumi), Alexandria University, Egypt. Corresponding author: Nader H.L. Bayoumi, MD, PhD, FRCS(G), Faculty of Medicine, Alexandria University, 311, Horeya Ave, Sporting, 10th Floor, App 1004, Alexandria, Egypt. Email: [email protected]. Q 2019 ASCRS and ESCRS Published by Elsevier Inc.
0886-3350/$ - see frontmatter https://doi.org/10.1016/j.jcrs.2019.07.031
PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
of the presence of PAS. Several IOP-lowering medications have shown to be effective in cases of PACG.9–11 Classic filtering surgery (trabeculectomy) has a good success rate,12,13 although it is associated with considerable risk and complications.14 More recently, lens removal through phacoemulsification, which debulks the anterior segment, has been reported to be a successful treatment option.15 Attempts to treat the angle pathology (PAS) through goniosynechialysis have been reported16; the success has been variable. More aggressive angle surgery, namely trabeculotomy ab externo, has been attempted, again with variable success.17 Given the relatively high risk for complications inherent in filtering surgery in PACG cases and the relative safety of angle procedures, it would be reasonable to hypothesize that combining lens removal (phacoemulsification) with angle surgery would be a safer, more effective procedure than combining it with filtering surgery. This study compared the outcomes of PACG treatment using combined phacoemulsification, viscosynechialysis, and trabeculotomy with those of combined phacoemulsification and trabeculectomy. Given the ethical and medical concerns regarding the removal of a clear healthy natural crystalline lens, the study was restricted to eyes with PACG that also had visually significant cataract.
PATIENTS AND METHODS This randomized controlled trial comprised 59 eyes treated for medically uncontrolled PACG and with a visually significant cataract at Mansoura Ophthalmic Center, Mansoura University, Egypt, between March 2012 and January 2017. Patients were recruited sequentially and were included in the study if they had (1) PACG and visually significant cataract, (2) a patent iridotomy, (3) a logarithm of the minimum angle of resolution (logMAR) corrected distance visual acuity (CDVA) of 0.4 or worse, (4) synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy, (5) an IOP greater than 21 mm Hg despite maximally tolerated IOPlowering medication, (6) no history of intraocular surgery other than laser iridotomy or surgical iridectomy, and (7) no severe systemic disease. The university’s ethics committee approved the study, and all patients provided written informed consent. Primary ACG was defined by the presence of elevated IOP (O21 mm Hg) and synechial angle closure of a gonioscopically narrow angle with optic nerve cupping typical of glaucoma and corresponding matching visual field defects. Lens opacity was considered visually significant if the patient reported any functional visual disability that might be related to the lens opacity and had a CDVA of 0.4 logMAR or worse. If both eyes were eligible for the study, the eye with the denser cataract was included in the analysis. All included patients had presented for the first time to the study facility. Patients with an acute attack of chronic ACG or with a known recent attack of chronic ACG were excluded; these parameters were ascertained from the patient history and whether there was a clinical report suggestive of chronic ACG. In all cases, a thorough history was taken and an ophthalmic examination performed. The CDVA was measured using a Snellen chart and then converted into logMAR notation. The IOP was measured using Goldmann applanation tonometry; 3 measurements were obtained, and the values were averaged. Gonioscopy, including dynamic (indentation) gonioscopy, was performed to confirm the diagnosis of angle closure and assess the degree of synechia (assessed subjectively by the examiner). Ultrasound
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biometry was performed, and the anterior chamber depth (ACD) was recorded. Patients were then scheduled for surgery. Randomization Eyes were randomized (computerized random-number generator) to receive phacoemulsification–viscosynechialysis–trabeculotomy (phaco–viscosynechialysis group) or a standard phacotrabeculectomy (phacotrabeculectomy group). In both groups, the phacoemulsification was performed through a separate corneal incision in a standard manner. Surgical Technique All surgeries were performed by the same surgeon (A.S.E.). After a fornix-based conjunctival flap was created, a partial-thickness (50%) triangular (4.0 mm 4.0 mm 4.0 mm) scleral flap was dissected. In the phaco–viscosynechialysis group, a radial incision straddling the limbus was created until localization of Schlemm canal until the Schlemm canal was identified, by the first ooze of clear fluid, and/or the visualization of the glistening circumferential fibers of the scleral spur. This was followed by deroofing part of the wall of Schlemm canal and injecting a high-viscosity ophthalmic viscosurgical device (sodium hyaluronate 1.4% [Healon GV]) into the open ends of Schlemm canal. A standard phacoemulsification procedure with intraocular lens (IOL) implantation was performed through a separate corneal incision. Next, the highviscosity sodium hyaluronate was injected over the entire circumference of the anterior chamber angle (360 degrees) to break the PAS; if the iris did not visibly fall posteriorly after the injection, a cannula was used to place pressure on the iris in some cases. An intraoperative goniolens was not available at the time of the study and thus was not used in any procedure. An ab externo trabeculotomy was then performed using a standard Harm’s trabeculotome on both sides of the incision opening. The trabeculectomy was approximately one third of the entire angle circumference. Finally, the scleral and conjunctival flaps were tightly closed. Standard phacoemulsification and IOL implantation were performed in the phacotrabeculectomy group. Next, a trabeculectomy (without an antimetabolite) and a peripheral iridectomy were performed. Finally, the scleral and conjunctival flaps were closed. Postoperative treatment was the same in both groups and comprised topical dexamethasone and ofloxacin eyedrops 5 times a day and cyclopentolate 3 times a day. The steroid and antibiotic eyedrops were tapered gradually over 5 weeks; the cycloplegic eyedrops were discontinued at the end of the first postoperative week. Postoperative Assessment Gonioscopy was performed in the early postoperative period to determine to ensure that the intraoperative synechialysis had been successful. In addition, patients were examined at 1 day and 7 days to detect early postoperative events or complications and then at 1, 3, 6, 9, 12, 18, and 24 months, at which time a complete ophthalmic evaluation was performed. Ultrasound biomicroscopy (Vumax, Sonomed Escalon) with a 48 MHz probe was performed at 3 months to determine the ACD, the presence of goniosynechiae, and the extent of the goniosynechiae, if present. Outcomes Measures The primary outcome measure was the reduction in IOP postoperatively compared with preoperative values. Secondary outcome measures included the change in CDVA, number of IOPlowering medications, and anterior chamber angle morphology. Success was defined as an IOP of 6 to 18 mm Hg without visionthreatening complications and without the need for additional glaucoma surgical procedures. The success was considered qualified if IOP-lowering medications were needed or true if they were not. Volume 45 Issue 12 December 2019
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Statistical Analysis Data were analyzed using SPSS software (version 20, IBM Corp.). Repeated-measure analysis of variance and paired t tests were used to compare the preoperative values and postoperative values within each group. The comparison between the 2 groups was performed with an independent-sample t test for numerical variables. Kaplan-Meier survival curves were plotted to estimate the mean survival time and probabilities of failure at different timepoints. For all tests, a P value less than 0.05 was considered significant.
RESULTS The study comprised 59 eyes of 59 patients. Table 1 shows the demographic and clinical characteristics of the patients by group. There were no statistically significant differences between the 2 groups in the age (P Z .704), sex (P Z 1.0), preoperative IOP (P Z .574), cup-to-disc (c/d) ratio (P Z .715), number of IOP-lowering medications
(P Z .897), CDVA (P Z .950), extent of PAS (P Z .837), ACD (P Z .475), visual field mean deviation (P Z .524), or visual field pattern standard deviation (P Z .396). The values of the latter 2 parameters showed that all the eyes had moderate to severe glaucoma. Table 2 shows the preoperative IOP and the postoperative IOP over time. There was a statistically significant reduction in IOP from the preoperative value in both groups at all postoperative timepoints (P ! .001). The IOP in the phaco–viscosynechialysis group was statistically significantly lower than in the phacotrabeculectomy group at all follow-ups (P ! .001). Figure 1 shows the preoperative IOP and postoperative IOP over time. There was a marked reduction in IOP in both groups in the first postoperative month; the decrease was greater in the phaco– viscosynechialysis group. This was followed by a gradual
Table 1. Patient demographic and baseline clinical characteristics. Parameter Patients, n (%) Male Female Eyes (%) Right Left Age (y) Mean G SD Range Median PAS extent ( ) Mean G SD Range Median ACD (mm) Mean G SD Range Median IOP-lowering medications (n) Mean G SD Range Median CDVA (logMAR) Mean G SD Range Median C/D ratio Mean G SD Range Median Visual field data (dB) Mean Deviation Mean G SD Range Median Pattern standard deviation Mean G SD Range Median
Phaco–Viscosynechiolysis (n Z 30)
Phacotrabeculectomy (n Z 29)
11 (36.7) 19 (63.3) 13 (43.3) 17 (56.7)
11 (37.9) 18 (62.1) 29 (100.0) 14 (48.3) 15 (51.7)
59.8 G 6.8 49, 78 58.5
60.3 G 6.3 50, 77 58
270.0 G 47.2 210, 330 240
268.9 G 49.7 210, 330 240
1.72 G 0.05 1.59, 1.84 1.73
1.71 G 0.06 1.61, 1.85 1.71
3.2 G 0.6 2, 4 3
3.2 G 0.6 2, 4 3
0.74 G 0.17 0.4, 1.0 0.7
0.74 G 0.16 0.4, 1.0 0.7
0.61 G 0.12 0.5, 0.9 0.6
0.62 G 0.12 0.5, 0.9 0.6
11.70 G 5.06 24.82, 5.32 0.48
12.10 G 4.39 22.72, 4.93 11.55
6.38 G 1.35 3.6, 9.1 6.3
6.58 G 1.23 3.8, 8.7 6.8
ACD Z anterior chamber depth; C/D Z cup-to-disc; CDVA Z corrected distance visual acuity; IOP Z intraocular pressure; PAS Z peripheral anterior synechia
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Table 2. Intraocular pressure over time. Intraocular Pressure (mm Hg) Postoperative Group Phaco– viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median
Preoperative*
1 Mo
3 Mo
6 Mo
9 Mo
12 Mo
18 Mo
24 Mo
28.7 G 2.14 25, 35 28
10.36 G 1.3 8, 14 10
11.5 G 1.2 9, 15 11.5
12.2 G 1.3 10, 16 12
12.5 G 1.1 11, 16 12
13.0 G 1.2 11, 17 13
13.7 G 1.6 12, 18 13
14.5 G 2. 8 11, 22 14
28.5 G 2.11 26, 34 28
12.8 G 1.1 11, 16 13
13.7 G 1.0 12, 16 14
14.8 G 1.2 13, 17 15
15.6 G 1.2 14, 18 16
16.1 G 1.1 15, 19 16
16.6 G 0.9 15, 19 16
17.3 G 2.2 15, 23 17
*On maximum intraocular pressure–lowering therapy
increase over the 24-month follow-up; the increase was greater in the phacotrabeculectomy group. The final measured IOP was significantly lower than the preoperative IOP in both groups (Figure 2). Table 3 shows the patients’ clinical characteristics 24 months postoperatively. There was a statistically significant reduction in the number of IOP-lowering medications postoperatively (P ! .001); however, there was no statistically significant difference between the 2 study groups (P Z .466). There was a statistically significant improvement in the CDVA from the preoperative values in both groups (P ! .001); the improvement was statistically significant greater in the phaco–viscosynechialysis group than in the phacotrabeculectomy group (P Z .039). The anterior chamber was significantly deeper than preoperatively in both groups (P ! .001); it was statistically significantly deeper in the phaco–viscosynechialysis group than in the phacotrabeculectomy group (P Z .001). There was a statistically significant reduction in the degree of PAS after surgery in both groups (P ! .001); the degree of PAS was statistically significantly less in the phaco–viscosynechialysis group than in the
phacotrabeculectomy group (P Z .020). The c/d ratio (P Z .476) and the visual field indices (mean deviation, pattern standard deviation) (P Z .258 and P Z .727, respectively) did not change significantly from the preoperative values nor were they significantly different between the 2 groups. Table 4 shows the success rates at the end of the 24 months. Both groups had a significant number of true success cases, although the percentage was greater in the phaco–viscosynechialysis group than in the phacotrabeculectomy group. Figure 3 shows the Kaplan-Meier survival curves for both groups. The mean survival time was 23.7 months G 0.17 (SD) in the phaco–viscosynechialysis group and 23.4 G 0.23 months in the phacotrabeculectomy group (P Z .361). The success probability was 100% in both groups at 12 months and 90% in the phaco– viscosynechialysis group and 81.5% phacotrabeculectomy group at 24 months. Table 5 shows the postoperative complications. A mild hyphema was seen in the majority of phaco– viscosynechialysis cases; the incidence was statistically significantly higher than in phacotrabeculectomy group
Figure 1. Preoperative IOP and postoperative IOP over time (Group A Z phaco–viscosynechialysis group; Group B Z phacotrabeculectomy group; IOP Z intraocular pressure).
Figure 2. Intraocular pressure trend over time (Group A Z phaco– viscosynechialysis group; Group B Z phacotrabeculectomy group; IOP Z intraocular pressure). Volume 45 Issue 12 December 2019
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Table 3. Clinical characteristics at 24-month follow-up.
Table 3. (Cont.)
Parameter
Parameter
IOP-lowering meds (n) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median CDVA (logMAR) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median PAS extent ( ) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median ACD (mm) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median C/D ratio Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median Visual field MD (dB) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median Visual field PSD (dB) Phaco–viscosynechiolysis Mean G SD Range
Preop
24 Mo Postop
3.2 G 0.6 2, 4 3
0.5 G 1.1 0, 3 0
3.2 G 0.6 2, 4 3
0.8 G 1.2 0, 3 0
0.74 G 0.17 0.4, 1.0 0.7
0.37 G 0.14 0.1, 0.7 0.4
0.74 G 0.16 0.4, 1.0 0.7
0.46 G 0.16 0.2, 0.8 0.5
270.0 G 47.2 210, 330 240
147.3 G 27.0 110, 220 150
268.9 G 49.7 210, 330 240
182.7 G 48.1 130, 300 180
1.72 G 0.05 1.59, 1.84 1.73
3.71 G 0.21 3.21, 4.13 3.74
1.71 G 0.06 1.61, 1.85 1.71
3.51 G 0.17 3.26, 3.94 3.53
0.61 G 0.12 0.5, 0.9 0.6
0.62 G 0.11 0.5, 0.9 0.6
0.62 G 0.12 0.5, 0.9 0.6
0.64 G 0.12 0.5, 0.9 0.6
11.7 G 5.06 24.82, 5.32 10.48
10.8 G 4.90 23.67, 5.24 9.78
12.1 G 4.39 22.72, 4.93 11.55
11.6 G 4.36 23.12, 4.82 11.12
6.38 G 1.35 3.6, 9.1
6.88 G 1.47 3.9, 9.6
(continued on next column)
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Median Phacotrabeculectomy Mean G SD Range Median
Preop
24 Mo Postop
6.3
6.7
6.58 G 1.23 3.8, 8.7 6.8
6.77 G 1.13 4.4, 8.7 6.7
ACD Z anterior chamber depth; C/D Z cup-to-disc; CDVA Z corrected distance visual acuity; IOP Z intraocular pressure; MD Z mean deviation; PAS Z peripheral anterior synechia; PSD Z pattern standard deviation
(P ! .001). The hyphema was self-limited in all cases. Statistically significantly more eyes in the phaco– viscosynechialysis group developed an unplanned flat bleb, while statistically significantly more eyes in the phacotrabeculectomy group developed a flat bleb. There was no statistically significant between-group difference in the other complications. DISCUSSION This study compared angle surgery and filtering surgery, both combined with phacoemulsification, in eyes with chronic synechial ACG and visually significant cataract. Combining phacoemulsification and angle surgery (viscosynechialysis with trabeculotomy) led to a significantly greater reduction in IOP than combining phacoemulsification with standard filtering surgery (trabeculectomy). Both study groups had a prevalence of women (almost two thirds in each group). This reflects the reported prevalence of PACG in women.8,18 The study patients were in the seventh decade of life, which underscores that PACG is a disease that presents later in life, as reported by He et al.19 and Day et al.20 In addition, the PAS involved almost three quarters of the angle, which might partly explain the lack of an adequate response to IOP-lowering medications. It also justifies our approach to the angle. The strategy of combining phacoemulsification and angle surgery in eyes with relatively extensive PAS has been reported, with techniques including combined goniosynechialysis and trabeculotomy,17 synechialysis alone,16 and combined phacoemulsification and filtering surgery.21 To our knowledge, ours is the first study to compare a combination of both angle procedures (ie, synechialysis and trabeculotomy) in
Table 4. Success at 24-month follow-up. Finding Qualified success Phaco–viscosynechiolysis Phacotrabeculectomy True success Phaco–viscosynechiolysis Phacotrabeculectomy Failure Phaco–viscosynechiolysis Phacotrabeculectomy
Number (%) 4 (13.3) 4 (13.8) 23 (76.7) 20 (69.0) 3 (10.0) 5 (17.2)
PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
Figure 3. Kaplan-Meier survival curves (Group A Z phacotrabeculectomy group; Group B Z phaco–viscosynechialysis group).
a randomized controlled trial and a standard filtering procedure, with both procedures combined with phacoemulsification. The beneficial effect of phacoemulsification in PACG is well established.15,22 The eyes in our study had shallow anterior chambers, which confirms that that PACG is more common in hyperopic eyes, which have a small, crowded anterior segment.23,24 In addition, the visual field data showed that all study eyes had moderate to severe glaucoma damage. Both findings further justify a rather aggressive treatment approach (ie, lens surgery) in these eyes. The postoperative outcomes reflect the success of both procedures in lowering IOP and with minimal complications. All eyes had a marked reduction in IOP followed by a gradual increase over the 24-month follow-up; despite this gradual rise, the IOP was lower than preoperatively in both groups. A reduction in IOP in eyes with in PACG has been reported with other procedures, including phacoemulsification alone,15,25 phacoemulsification with filtering surgery,25 filtering surgery alone,26 and phacoemulsification with trabeculotomy.17 In our study, the angle procedure had a clear advantage over the filtering procedure in terms of IOP reduction. The reduction in IOP-lowering medications was comparable between the 2 groups, which agrees with findings in
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other reports.27,28 An improvement in CDVA is expected after a successful phacoemulsification procedure and in our study was comparable between the 2 groups. Because the visual field mean deviation reflects the overall height of the hill of vision, it was not surprising to find a mild improvement postoperatively that paralleled the improvement in CDVA. The improvement in the visual field mean deviation was a result of the restoration of media clarity, a finding that is in agreement with other reports.29,30 Studies16,27 have reported that phacoemulsification deepens the anterior chamber. Given the neuronal damage in PACG, as reflected by an advanced c/d ratio, it is not surprising that the c/d ratio did not improve in either group. However, the stability of the ratio over 2 years and the relatively stable visual field pattern standard deviation indicate fairly good control of IOP. There are many possible reasons for the IOP reduction in the current study. One is the debulking of the anterior segment resulting from the lensectomy (phacoemulsification). This deepened the anterior chamber and subsequently widened the anterior chamber angle, increasing filtration and lowering the IOP; this mechanism has been previously reported.15,27 The fluidics inherent in the phacoemulsification procedure cannot be overlooked given the positive pressure maintained in the anterior segment of the eye during the entire procedure. This might act as a posterior vector force on the iris, possibly resulting in breakage of some of the PAS. In our study, there was a reduction in the degree of the PAS, even in the phacotrabeculectomy eyes in which no specific synechialysis was performed. In eyes in which viscosynechialysis was performed, restoration of a functioning open angle would explain the reduction in IOP, especially when combined with ab externo trabeculotomy, which allows access of aqueous humor directly to the canal of Schlemm and breaks residual PAS in the area of passage of the trabeculotome. The complications in the current study were minimal and not vision threatening. Minimal regurgitation of blood into the anterior chamber is expected to cause a mild hyphema because synechialysis opens the angle to a greater degree and trabeculotomy exposes Schlemm canal and its valveless collector channels to the anterior chamber; the hyphema was self-limited in all affected eyes. This complication of
Table 5. Complications and repeat interventions. Number (%) Finding Hyphema* Flat bleb* Filtering bleb* Descemet membrane detachment IOP elevation O20 mm Hg Corneal edema Fibrin exudation Shallow anterior chamber
Phaco-Viscosynechiolysis
Phacotrabeculectomy
26 (86.66) 27 (90) 3 (10) 6 (20) 3 (10) 2 (6.7) 1 (3.3) 1 (3.3)
3 (10.34) 5 (17.24) 24 (82.76) 2 (6.9) 5 (17.24) 3 (10.34) 2 (6.9) 1 (3.45)
IOP Z intraocular pressure *Statistically significant
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synechialysis has been previously reported.28 There were a few cases of fibrosis or scarred flat blebs in the phacotrabeculectomy group, which is in accordance with findings in other studies.31 Although phaco–synechialysis is not primarily a filtering procedure, a bleb formed in a few eyes in that group. We hypothesize that defective closure of the scleral flap might have been the underlying cause. Finally, the occurrence of a limited Descemet membrane detachment with ab externo trabeculotomy parallels results in previous reports.17 The current study has limitations. The relatively small number of eyes included precludes robust generalization of the our results. Performing synechialysis with the use of intraoperative gonioscopy would have allowed a more controlled procedure under direct visualization. The lack of preoperative anterior segment imaging to objectively assess the extent of PAS and the configuration of the anterior chamber angle is another issue. However, this limitation was offset by the assessment of the study cases by an experienced consultant (A.S.E.). That the study eyes had a peripheral iridotomy/iridectomy might have affected some outcomes, such as the preoperative assessment of the angle configuration and the ACD findings on ultrasound biomicroscopy and might have affected the IOP outcomes. In conclusion, both phacoemulsification–viscosynechialysis–trabeculotomy and phacotrabeculectomy were relatively safe and effective in reducing the IOP in eyes with PACG for at least 2 years, with phaco–viscosynechialysis–trabeculotomy being more advantageous than phacotrabeculectomy.
WHAT WAS KNOWN Lens extraction increases the depth of the anterior chamber and the width of the angle and helps lower the intraocular pressure (IOP) in eyes with primary angle-closure glaucoma (PACG). Phacotrabeculectomy reduces the IOP in eyes with chronic PACG.
WHAT THIS PAPER ADDS Viscosynechialysis combined with phacoemulsification and trabeculotomy yielded a greater reduction in the IOP than phacotrabeculectomy in eyes with chronic PACG and visually significant cataract.
REFERENCES 1. Liu S-A, Zhao Z-N, Sun N-N, Han Y, Chen J, Fan Z-G. Transitions of the understanding and definition of primary glaucoma. Chin Med J (Engl) 2018; 131:2852–2859 2. Bordeianu CD. [Criticism of the gonioscopic classifications of the glaucoma: with particular reference to the classification issued by the European Glaucoma Society in 2008]. [Romanian]. Oftalmologia 2014; 58 (3):7–22 3. Wright C, Tawfik MA, Waisbourd M, Katz LJ. Primary angle-closure glaucoma: an update. Acta Ophthalmol 2016; 94:217–225 4. Tham Y-C, Li X, Wong TY, Quigley HA, Aung T, Cheng C-Y. Global prevalence of glaucoma and projections of glaucoma burden through 2040; a systematic review and meta-analysis. Ophthalmology 2014; 121:2081– 2090
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5. Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol 2002; 86:238–242 6. He M, Jiang Y, Huang S, Chang DS, Munoz B, Aung T, Foster PJ, Friedman DS. Laser peripheral iridotomy for the prevention of angle closure: A single-centre, randomised controlled trial. Lancet 2019; 393:1609–1618 7. Rao A, Rao HL, Kumar AU, Babu JG, Madhulata U, Arthi J, Tukaram M, Senthil S, Garudadri CS. Outcomes of laser peripheral iridotomy in angle closure disease. Semin Ophthalmol 2013; 28:4–8 8. Pillunat KR, Spoerl E, Orphal J, Pillunat LE. Argon laser peripheral iridoplasty for chronic primary angle-closure and angle-closure glaucoma in caucasians. Acta Ophthalmol 2019; 97:e225–e230 9. Rao A, Rao HL, Senthil S, Garudadri CS. Varied clinical course in plateau iris syndrome: a case series. Semin Ophthalmol 2013; 28:28–31 10. Aung T, Wong HT, Yip CC, Leong JYN, Chan Y-H, Chew PTK. Comparison of the intraocular pressure-lowering effect of latanoprost and timolol in patients with chronic angle closure glaucoma; a preliminary study. Ophthalmology 2000; 107:1178–1183 11. Kim JM, Park KH, Kim CY, Kim HK, Kim T-W, Kim MS. Effects of brimonidine timolol fixed combination therapy on anterior ocular segment configuration. Jpn J Ophthalmol 2011; 55:356–361 12. Bevin TH, Molteno ACB, Herbison P. Otago Glaucoma Surgery Outcome Study: long-term results of 841 trabeculectomies. Clin Exp Ophthalmol 2008; 36:731–737 13. Ng WT, Morgan W. Mechanisms and treatment of primary angle closure: a review. Clin Exp Ophthalmol 2012; 40:e218–e228 14. Tham CCY, Kwong YYY, Baig N, Leung DYL, Li FCH, Lam DSC. Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology 2013; 120:62– 67 15. Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J, for the EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. Lancet 2016; 388:1389–1397 16. Zhang H, Tang G, Liu J. Effects of phacoemulsification combined with goniosynechialysis on primary angle-closure glaucoma. J Glaucoma 2016; 25:e499–e503 17. Kiuchi Y, Tsujino C, Nakamura T, Otori Y, Mochizuki H. Phacoemulsification and trabeculotomy combined with goniosynechialysis for uncontrollable chronic angle-closure glaucoma. Ophthalmic Surg Lasers Imaging 2010; 41:348–354 18. Liang Y, Friedman DS, Zhou Q, Yang XH, Sun LP, Guo L, Chang DS, Lian L, Wang NL. for the Handan Eye Study Group. Prevalence and characteristics of primary angle-closure diseases in a rural adult Chinese population: the Handan eye study. Invest Ophthalmol Vis Sci 2011; 52:8672–8679 19. He M, Foster PJ, Johnson GJ, Khaw PT. Angle-closure glaucoma in East Asian and European people. Different diseases? Eye 2006; 20:3–12 20. Day AC, Baio G, Gazzard G, Bunce C, Azuara-Blanco A, Munoz B, Friedman DS, Foster PJ. The prevalence of primary angle closure glaucoma in European derived populations: a systematic review. Br J Ophthalmol 2012; 96:1162–1167 21. Song BJ, Ramanathan M, Morales E, Law SK, Giaconi JA, Coleman AL, Caprioli J. Trabeculectomy and combined phacoemulsificationtrabeculectomy: outcomes and risk factors for failure in primary angle closure glaucoma. J Glaucoma 2016; 25:763–769 22. Chan PP, Li EY, Tsoi KKF, Kwong YY, Tham CC. Cost-effectiveness of phacoemulsification versus combined phacotrabeculectomy for treating primary angle closure glaucoma. J Glaucoma 2017; 26:911–922 23. Nongpiur ME, He M, Amerasinghe N, Friedman DS, Tay W-T, Baskaran M, Smith SD, Wong TY, Aung T. Lens vault, thickness, and position in Chinese subjects with angle closure. Ophthalmology 2011; 118:474–479 24. Winegarner A, Miki A, Kumoi M, Ishida Y, Wakabayashi T, Sakimoto S, Usui S, Matsushita K, Nishida K. Anterior segment Scheimpflug for detecting primary angle closure disease. Graefes Arch Clin Exp Ophthalmol 2019; 257:161–167 25. Tham CCY, Kwong YYY, Leung DYL, Lam SW, Li FCH, Chiu TYH, Chan JCH, Lam DSC, Lai JSM. Phacoemulsification versus combined phacotrabeculectomy in medically uncontrolled chronic angle closure glaucoma with cataracts. Ophthalmology 2009; 116:725–731 26. Zhang X, Teng L, Li A, Du S, Zhu Y, Ge J. The clinical outcomes of three surgical managements on primary angle-closure glaucoma. Yan Ke Xue Bao 2007; 23:65–74 27. Rodrigues IA, Alaghband P, Beltran Agullo L, Galvis E, Jones S, Husain R, Lim KS. Aqueous outflow facility after phacoemulsification with or without goniosynechialysis in primary angle closure: a randomised controlled study. Br J Ophthalmol 2017; 101:879–885
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28. Zhao X-j, Yang X-x, Fan Y-p, Li B-h, Li Q. Comparison of combined phacoemulsification, intraocular lens implantation, and goniosynechialysis with Phacotrabeculectomy in the treatment of primary angle-closure glaucoma and cataract. Asia Pac J Ophthalmol 2013; 2:286–290 29. Bojikian KD, Chen PP. Intraocular pressure after phacoemulsification in open-angle glaucoma patients with uncontrolled or marginally controlled glaucoma and/or with severe visual field loss. J Glaucoma 2018; 27:108–114 30. Seol BR, Jeoung JW, Park KH. Changes of visual-field global indices after cataract surgery in primary open-angle glaucoma patients. Jpn J Ophthalmol 2016; 60:439–445 31. Koh V, Chen D, Aquino CM, Aduan J, Sng C, Chee LS, Chew P. Success rates of 2-site phacoemulsification combined with fornix-based trabeculectomy using mitomycin C for primary angle-closure glaucoma and primary open-angle glaucoma in an Asian population. Jpn J Ophthalmol 2017; 61:245–252
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Disclosures: None of the authors has a financial or proprietary interest in any material or methods mentioned.
First author: Ahmed S. Elwehidy, MD, PhD Faculty of Medicine, Mansoura University, Egypt
Volume 45 Issue 12 December 2019
ARTICLE
Combined phacoemulsification–viscosynechialysis– trabeculotomy vs phacotrabeculectomy in uncontrolled primary angle-closure glaucoma with cataract Ahmed S. Elwehidy, MD, PhD, Nader H.L. Bayoumi, MD, PhD, FRCS(G), Amani E. Badawi, MD, PhD, Sherein M. Hagras, MD, PhD, Rania Kamel, MD, PhD
Purpose: To compare the effect on intraocular pressure (IOP) of phacoemulsification combined with viscosynechialysis and trabeculotomy with that of phacoemulsification combined with trabeculectomy in eyes with primary angle-closure glaucoma (PACG) and visually significant cataract.
Setting: Mansoura Ophthalmic Center, Mansoura University, Egypt.
Design: Prospective case series. Methods: This prospective randomized study included patients with uncontrolled PACG and visually significant cataract presenting between 2012 and 2017. The eyes were randomized to phacoemulsification combined with viscosynechialysis and trabeculotomy (phaco–viscosynechialysis group) or phacoemulsification combined with trabeculectomy (phacotrabeculectomy group). Success (true and qualified) (IOP <18 mm Hg without sight-threatening complications) was studied 24 months postoperatively.
G
laucoma is a type of optic neuropathy characterized by optic nerve damage (cupping) associated with corresponding visual field changes. Intraocular pressure (IOP) can be a significant factor in the development of this condition.1 Glaucoma is classified etiologically into primary and secondary entities, each of which is further classified gonioscopically into open angle and narrow (closed) angle based on the configuration of the anterior chamber angle.2 Narrow-angle glaucoma represents 26% of glaucoma cases worldwide3 and is more prevalent in the Middle East and
Intraoperative complications were noted. The primary outcome measure was the IOP before and after surgery.
Results: The study comprised 59 eyes of 59 patients with a mean age of 59.8 years G 6.8 (SD) in the phaco–viscosynechialysis group (30 eyes) and 60.3 G 6.3 years in the phacotrabeculectomy group (29 eyes) (P Z .704). The mean preoperative IOP was 28.7 G 2.14 mm Hg in the phaco–viscosynechialysis group and 28.5 G 2.11 mm Hg in the phacotrabeculectomy group; the mean at 24 months was 14.5 G 2.8 mm Hg and 17.3 G 2.2 mm Hg, respectively (P < .001). The total success rate at 24 months was 90% and 83%, respectively. Conclusion: Although both techniques were relatively safe and effective in reducing IOP for at least 2 years in eyes with PACG, combined phacoemulsification–viscosynechialysis–trabeculotomy gave better outcomes. J Cataract Refract Surg 2019; 45:1738–1745 Q 2019 ASCRS and ESCRS
Southeast Asia.4 Foster et al.5 recently classified primary angle closure (PAC) as PAC suspect (with appositional narrow angle), PAC (evidence of previous iridocorneal contact without affecting the optic nerve), and PAC glaucoma (with peripheral anterior synechiae [PAS] with optic nerve cupping associated with corresponding visual field defects), known classically as primary angle-closure glaucoma (PACG). Primary angle-closure suspect cases can be managed with peripheral laser iridotomy6,7 to relieve the pupil block or with argon laser peripheral iridoplasty.8 Eyes with PACG require more elaborate treatment because
Submitted: March 26, 2019 | Final revision submitted: July 25, 2019 | Accepted: July 29, 2019 From the Faculty of Medicine (Elwehidy, Badawi, Hagras, Kamel), Mansoura University, and Faculty of Medicine (Bayoumi), Alexandria University, Egypt. Corresponding author: Nader H.L. Bayoumi, MD, PhD, FRCS(G), Faculty of Medicine, Alexandria University, 311, Horeya Ave, Sporting, 10th Floor, App 1004, Alexandria, Egypt. Email: [email protected]. Q 2019 ASCRS and ESCRS Published by Elsevier Inc.
0886-3350/$ - see frontmatter https://doi.org/10.1016/j.jcrs.2019.07.031
PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
of the presence of PAS. Several IOP-lowering medications have shown to be effective in cases of PACG.9–11 Classic filtering surgery (trabeculectomy) has a good success rate,12,13 although it is associated with considerable risk and complications.14 More recently, lens removal through phacoemulsification, which debulks the anterior segment, has been reported to be a successful treatment option.15 Attempts to treat the angle pathology (PAS) through goniosynechialysis have been reported16; the success has been variable. More aggressive angle surgery, namely trabeculotomy ab externo, has been attempted, again with variable success.17 Given the relatively high risk for complications inherent in filtering surgery in PACG cases and the relative safety of angle procedures, it would be reasonable to hypothesize that combining lens removal (phacoemulsification) with angle surgery would be a safer, more effective procedure than combining it with filtering surgery. This study compared the outcomes of PACG treatment using combined phacoemulsification, viscosynechialysis, and trabeculotomy with those of combined phacoemulsification and trabeculectomy. Given the ethical and medical concerns regarding the removal of a clear healthy natural crystalline lens, the study was restricted to eyes with PACG that also had visually significant cataract.
PATIENTS AND METHODS This randomized controlled trial comprised 59 eyes treated for medically uncontrolled PACG and with a visually significant cataract at Mansoura Ophthalmic Center, Mansoura University, Egypt, between March 2012 and January 2017. Patients were recruited sequentially and were included in the study if they had (1) PACG and visually significant cataract, (2) a patent iridotomy, (3) a logarithm of the minimum angle of resolution (logMAR) corrected distance visual acuity (CDVA) of 0.4 or worse, (4) synechial angle closure of more than 180 degrees that occluded the trabecular meshwork as confirmed by indentation gonioscopy, (5) an IOP greater than 21 mm Hg despite maximally tolerated IOPlowering medication, (6) no history of intraocular surgery other than laser iridotomy or surgical iridectomy, and (7) no severe systemic disease. The university’s ethics committee approved the study, and all patients provided written informed consent. Primary ACG was defined by the presence of elevated IOP (O21 mm Hg) and synechial angle closure of a gonioscopically narrow angle with optic nerve cupping typical of glaucoma and corresponding matching visual field defects. Lens opacity was considered visually significant if the patient reported any functional visual disability that might be related to the lens opacity and had a CDVA of 0.4 logMAR or worse. If both eyes were eligible for the study, the eye with the denser cataract was included in the analysis. All included patients had presented for the first time to the study facility. Patients with an acute attack of chronic ACG or with a known recent attack of chronic ACG were excluded; these parameters were ascertained from the patient history and whether there was a clinical report suggestive of chronic ACG. In all cases, a thorough history was taken and an ophthalmic examination performed. The CDVA was measured using a Snellen chart and then converted into logMAR notation. The IOP was measured using Goldmann applanation tonometry; 3 measurements were obtained, and the values were averaged. Gonioscopy, including dynamic (indentation) gonioscopy, was performed to confirm the diagnosis of angle closure and assess the degree of synechia (assessed subjectively by the examiner). Ultrasound
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biometry was performed, and the anterior chamber depth (ACD) was recorded. Patients were then scheduled for surgery. Randomization Eyes were randomized (computerized random-number generator) to receive phacoemulsification–viscosynechialysis–trabeculotomy (phaco–viscosynechialysis group) or a standard phacotrabeculectomy (phacotrabeculectomy group). In both groups, the phacoemulsification was performed through a separate corneal incision in a standard manner. Surgical Technique All surgeries were performed by the same surgeon (A.S.E.). After a fornix-based conjunctival flap was created, a partial-thickness (50%) triangular (4.0 mm 4.0 mm 4.0 mm) scleral flap was dissected. In the phaco–viscosynechialysis group, a radial incision straddling the limbus was created until localization of Schlemm canal until the Schlemm canal was identified, by the first ooze of clear fluid, and/or the visualization of the glistening circumferential fibers of the scleral spur. This was followed by deroofing part of the wall of Schlemm canal and injecting a high-viscosity ophthalmic viscosurgical device (sodium hyaluronate 1.4% [Healon GV]) into the open ends of Schlemm canal. A standard phacoemulsification procedure with intraocular lens (IOL) implantation was performed through a separate corneal incision. Next, the highviscosity sodium hyaluronate was injected over the entire circumference of the anterior chamber angle (360 degrees) to break the PAS; if the iris did not visibly fall posteriorly after the injection, a cannula was used to place pressure on the iris in some cases. An intraoperative goniolens was not available at the time of the study and thus was not used in any procedure. An ab externo trabeculotomy was then performed using a standard Harm’s trabeculotome on both sides of the incision opening. The trabeculectomy was approximately one third of the entire angle circumference. Finally, the scleral and conjunctival flaps were tightly closed. Standard phacoemulsification and IOL implantation were performed in the phacotrabeculectomy group. Next, a trabeculectomy (without an antimetabolite) and a peripheral iridectomy were performed. Finally, the scleral and conjunctival flaps were closed. Postoperative treatment was the same in both groups and comprised topical dexamethasone and ofloxacin eyedrops 5 times a day and cyclopentolate 3 times a day. The steroid and antibiotic eyedrops were tapered gradually over 5 weeks; the cycloplegic eyedrops were discontinued at the end of the first postoperative week. Postoperative Assessment Gonioscopy was performed in the early postoperative period to determine to ensure that the intraoperative synechialysis had been successful. In addition, patients were examined at 1 day and 7 days to detect early postoperative events or complications and then at 1, 3, 6, 9, 12, 18, and 24 months, at which time a complete ophthalmic evaluation was performed. Ultrasound biomicroscopy (Vumax, Sonomed Escalon) with a 48 MHz probe was performed at 3 months to determine the ACD, the presence of goniosynechiae, and the extent of the goniosynechiae, if present. Outcomes Measures The primary outcome measure was the reduction in IOP postoperatively compared with preoperative values. Secondary outcome measures included the change in CDVA, number of IOPlowering medications, and anterior chamber angle morphology. Success was defined as an IOP of 6 to 18 mm Hg without visionthreatening complications and without the need for additional glaucoma surgical procedures. The success was considered qualified if IOP-lowering medications were needed or true if they were not. Volume 45 Issue 12 December 2019
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Statistical Analysis Data were analyzed using SPSS software (version 20, IBM Corp.). Repeated-measure analysis of variance and paired t tests were used to compare the preoperative values and postoperative values within each group. The comparison between the 2 groups was performed with an independent-sample t test for numerical variables. Kaplan-Meier survival curves were plotted to estimate the mean survival time and probabilities of failure at different timepoints. For all tests, a P value less than 0.05 was considered significant.
RESULTS The study comprised 59 eyes of 59 patients. Table 1 shows the demographic and clinical characteristics of the patients by group. There were no statistically significant differences between the 2 groups in the age (P Z .704), sex (P Z 1.0), preoperative IOP (P Z .574), cup-to-disc (c/d) ratio (P Z .715), number of IOP-lowering medications
(P Z .897), CDVA (P Z .950), extent of PAS (P Z .837), ACD (P Z .475), visual field mean deviation (P Z .524), or visual field pattern standard deviation (P Z .396). The values of the latter 2 parameters showed that all the eyes had moderate to severe glaucoma. Table 2 shows the preoperative IOP and the postoperative IOP over time. There was a statistically significant reduction in IOP from the preoperative value in both groups at all postoperative timepoints (P ! .001). The IOP in the phaco–viscosynechialysis group was statistically significantly lower than in the phacotrabeculectomy group at all follow-ups (P ! .001). Figure 1 shows the preoperative IOP and postoperative IOP over time. There was a marked reduction in IOP in both groups in the first postoperative month; the decrease was greater in the phaco– viscosynechialysis group. This was followed by a gradual
Table 1. Patient demographic and baseline clinical characteristics. Parameter Patients, n (%) Male Female Eyes (%) Right Left Age (y) Mean G SD Range Median PAS extent ( ) Mean G SD Range Median ACD (mm) Mean G SD Range Median IOP-lowering medications (n) Mean G SD Range Median CDVA (logMAR) Mean G SD Range Median C/D ratio Mean G SD Range Median Visual field data (dB) Mean Deviation Mean G SD Range Median Pattern standard deviation Mean G SD Range Median
Phaco–Viscosynechiolysis (n Z 30)
Phacotrabeculectomy (n Z 29)
11 (36.7) 19 (63.3) 13 (43.3) 17 (56.7)
11 (37.9) 18 (62.1) 29 (100.0) 14 (48.3) 15 (51.7)
59.8 G 6.8 49, 78 58.5
60.3 G 6.3 50, 77 58
270.0 G 47.2 210, 330 240
268.9 G 49.7 210, 330 240
1.72 G 0.05 1.59, 1.84 1.73
1.71 G 0.06 1.61, 1.85 1.71
3.2 G 0.6 2, 4 3
3.2 G 0.6 2, 4 3
0.74 G 0.17 0.4, 1.0 0.7
0.74 G 0.16 0.4, 1.0 0.7
0.61 G 0.12 0.5, 0.9 0.6
0.62 G 0.12 0.5, 0.9 0.6
11.70 G 5.06 24.82, 5.32 0.48
12.10 G 4.39 22.72, 4.93 11.55
6.38 G 1.35 3.6, 9.1 6.3
6.58 G 1.23 3.8, 8.7 6.8
ACD Z anterior chamber depth; C/D Z cup-to-disc; CDVA Z corrected distance visual acuity; IOP Z intraocular pressure; PAS Z peripheral anterior synechia
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Table 2. Intraocular pressure over time. Intraocular Pressure (mm Hg) Postoperative Group Phaco– viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median
Preoperative*
1 Mo
3 Mo
6 Mo
9 Mo
12 Mo
18 Mo
24 Mo
28.7 G 2.14 25, 35 28
10.36 G 1.3 8, 14 10
11.5 G 1.2 9, 15 11.5
12.2 G 1.3 10, 16 12
12.5 G 1.1 11, 16 12
13.0 G 1.2 11, 17 13
13.7 G 1.6 12, 18 13
14.5 G 2. 8 11, 22 14
28.5 G 2.11 26, 34 28
12.8 G 1.1 11, 16 13
13.7 G 1.0 12, 16 14
14.8 G 1.2 13, 17 15
15.6 G 1.2 14, 18 16
16.1 G 1.1 15, 19 16
16.6 G 0.9 15, 19 16
17.3 G 2.2 15, 23 17
*On maximum intraocular pressure–lowering therapy
increase over the 24-month follow-up; the increase was greater in the phacotrabeculectomy group. The final measured IOP was significantly lower than the preoperative IOP in both groups (Figure 2). Table 3 shows the patients’ clinical characteristics 24 months postoperatively. There was a statistically significant reduction in the number of IOP-lowering medications postoperatively (P ! .001); however, there was no statistically significant difference between the 2 study groups (P Z .466). There was a statistically significant improvement in the CDVA from the preoperative values in both groups (P ! .001); the improvement was statistically significant greater in the phaco–viscosynechialysis group than in the phacotrabeculectomy group (P Z .039). The anterior chamber was significantly deeper than preoperatively in both groups (P ! .001); it was statistically significantly deeper in the phaco–viscosynechialysis group than in the phacotrabeculectomy group (P Z .001). There was a statistically significant reduction in the degree of PAS after surgery in both groups (P ! .001); the degree of PAS was statistically significantly less in the phaco–viscosynechialysis group than in the
phacotrabeculectomy group (P Z .020). The c/d ratio (P Z .476) and the visual field indices (mean deviation, pattern standard deviation) (P Z .258 and P Z .727, respectively) did not change significantly from the preoperative values nor were they significantly different between the 2 groups. Table 4 shows the success rates at the end of the 24 months. Both groups had a significant number of true success cases, although the percentage was greater in the phaco–viscosynechialysis group than in the phacotrabeculectomy group. Figure 3 shows the Kaplan-Meier survival curves for both groups. The mean survival time was 23.7 months G 0.17 (SD) in the phaco–viscosynechialysis group and 23.4 G 0.23 months in the phacotrabeculectomy group (P Z .361). The success probability was 100% in both groups at 12 months and 90% in the phaco– viscosynechialysis group and 81.5% phacotrabeculectomy group at 24 months. Table 5 shows the postoperative complications. A mild hyphema was seen in the majority of phaco– viscosynechialysis cases; the incidence was statistically significantly higher than in phacotrabeculectomy group
Figure 1. Preoperative IOP and postoperative IOP over time (Group A Z phaco–viscosynechialysis group; Group B Z phacotrabeculectomy group; IOP Z intraocular pressure).
Figure 2. Intraocular pressure trend over time (Group A Z phaco– viscosynechialysis group; Group B Z phacotrabeculectomy group; IOP Z intraocular pressure). Volume 45 Issue 12 December 2019
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PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
Table 3. Clinical characteristics at 24-month follow-up.
Table 3. (Cont.)
Parameter
Parameter
IOP-lowering meds (n) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median CDVA (logMAR) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median PAS extent ( ) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median ACD (mm) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median C/D ratio Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median Visual field MD (dB) Phaco–viscosynechiolysis Mean G SD Range Median Phacotrabeculectomy Mean G SD Range Median Visual field PSD (dB) Phaco–viscosynechiolysis Mean G SD Range
Preop
24 Mo Postop
3.2 G 0.6 2, 4 3
0.5 G 1.1 0, 3 0
3.2 G 0.6 2, 4 3
0.8 G 1.2 0, 3 0
0.74 G 0.17 0.4, 1.0 0.7
0.37 G 0.14 0.1, 0.7 0.4
0.74 G 0.16 0.4, 1.0 0.7
0.46 G 0.16 0.2, 0.8 0.5
270.0 G 47.2 210, 330 240
147.3 G 27.0 110, 220 150
268.9 G 49.7 210, 330 240
182.7 G 48.1 130, 300 180
1.72 G 0.05 1.59, 1.84 1.73
3.71 G 0.21 3.21, 4.13 3.74
1.71 G 0.06 1.61, 1.85 1.71
3.51 G 0.17 3.26, 3.94 3.53
0.61 G 0.12 0.5, 0.9 0.6
0.62 G 0.11 0.5, 0.9 0.6
0.62 G 0.12 0.5, 0.9 0.6
0.64 G 0.12 0.5, 0.9 0.6
11.7 G 5.06 24.82, 5.32 10.48
10.8 G 4.90 23.67, 5.24 9.78
12.1 G 4.39 22.72, 4.93 11.55
11.6 G 4.36 23.12, 4.82 11.12
6.38 G 1.35 3.6, 9.1
6.88 G 1.47 3.9, 9.6
(continued on next column)
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Median Phacotrabeculectomy Mean G SD Range Median
Preop
24 Mo Postop
6.3
6.7
6.58 G 1.23 3.8, 8.7 6.8
6.77 G 1.13 4.4, 8.7 6.7
ACD Z anterior chamber depth; C/D Z cup-to-disc; CDVA Z corrected distance visual acuity; IOP Z intraocular pressure; MD Z mean deviation; PAS Z peripheral anterior synechia; PSD Z pattern standard deviation
(P ! .001). The hyphema was self-limited in all cases. Statistically significantly more eyes in the phaco– viscosynechialysis group developed an unplanned flat bleb, while statistically significantly more eyes in the phacotrabeculectomy group developed a flat bleb. There was no statistically significant between-group difference in the other complications. DISCUSSION This study compared angle surgery and filtering surgery, both combined with phacoemulsification, in eyes with chronic synechial ACG and visually significant cataract. Combining phacoemulsification and angle surgery (viscosynechialysis with trabeculotomy) led to a significantly greater reduction in IOP than combining phacoemulsification with standard filtering surgery (trabeculectomy). Both study groups had a prevalence of women (almost two thirds in each group). This reflects the reported prevalence of PACG in women.8,18 The study patients were in the seventh decade of life, which underscores that PACG is a disease that presents later in life, as reported by He et al.19 and Day et al.20 In addition, the PAS involved almost three quarters of the angle, which might partly explain the lack of an adequate response to IOP-lowering medications. It also justifies our approach to the angle. The strategy of combining phacoemulsification and angle surgery in eyes with relatively extensive PAS has been reported, with techniques including combined goniosynechialysis and trabeculotomy,17 synechialysis alone,16 and combined phacoemulsification and filtering surgery.21 To our knowledge, ours is the first study to compare a combination of both angle procedures (ie, synechialysis and trabeculotomy) in
Table 4. Success at 24-month follow-up. Finding Qualified success Phaco–viscosynechiolysis Phacotrabeculectomy True success Phaco–viscosynechiolysis Phacotrabeculectomy Failure Phaco–viscosynechiolysis Phacotrabeculectomy
Number (%) 4 (13.3) 4 (13.8) 23 (76.7) 20 (69.0) 3 (10.0) 5 (17.2)
PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
Figure 3. Kaplan-Meier survival curves (Group A Z phacotrabeculectomy group; Group B Z phaco–viscosynechialysis group).
a randomized controlled trial and a standard filtering procedure, with both procedures combined with phacoemulsification. The beneficial effect of phacoemulsification in PACG is well established.15,22 The eyes in our study had shallow anterior chambers, which confirms that that PACG is more common in hyperopic eyes, which have a small, crowded anterior segment.23,24 In addition, the visual field data showed that all study eyes had moderate to severe glaucoma damage. Both findings further justify a rather aggressive treatment approach (ie, lens surgery) in these eyes. The postoperative outcomes reflect the success of both procedures in lowering IOP and with minimal complications. All eyes had a marked reduction in IOP followed by a gradual increase over the 24-month follow-up; despite this gradual rise, the IOP was lower than preoperatively in both groups. A reduction in IOP in eyes with in PACG has been reported with other procedures, including phacoemulsification alone,15,25 phacoemulsification with filtering surgery,25 filtering surgery alone,26 and phacoemulsification with trabeculotomy.17 In our study, the angle procedure had a clear advantage over the filtering procedure in terms of IOP reduction. The reduction in IOP-lowering medications was comparable between the 2 groups, which agrees with findings in
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other reports.27,28 An improvement in CDVA is expected after a successful phacoemulsification procedure and in our study was comparable between the 2 groups. Because the visual field mean deviation reflects the overall height of the hill of vision, it was not surprising to find a mild improvement postoperatively that paralleled the improvement in CDVA. The improvement in the visual field mean deviation was a result of the restoration of media clarity, a finding that is in agreement with other reports.29,30 Studies16,27 have reported that phacoemulsification deepens the anterior chamber. Given the neuronal damage in PACG, as reflected by an advanced c/d ratio, it is not surprising that the c/d ratio did not improve in either group. However, the stability of the ratio over 2 years and the relatively stable visual field pattern standard deviation indicate fairly good control of IOP. There are many possible reasons for the IOP reduction in the current study. One is the debulking of the anterior segment resulting from the lensectomy (phacoemulsification). This deepened the anterior chamber and subsequently widened the anterior chamber angle, increasing filtration and lowering the IOP; this mechanism has been previously reported.15,27 The fluidics inherent in the phacoemulsification procedure cannot be overlooked given the positive pressure maintained in the anterior segment of the eye during the entire procedure. This might act as a posterior vector force on the iris, possibly resulting in breakage of some of the PAS. In our study, there was a reduction in the degree of the PAS, even in the phacotrabeculectomy eyes in which no specific synechialysis was performed. In eyes in which viscosynechialysis was performed, restoration of a functioning open angle would explain the reduction in IOP, especially when combined with ab externo trabeculotomy, which allows access of aqueous humor directly to the canal of Schlemm and breaks residual PAS in the area of passage of the trabeculotome. The complications in the current study were minimal and not vision threatening. Minimal regurgitation of blood into the anterior chamber is expected to cause a mild hyphema because synechialysis opens the angle to a greater degree and trabeculotomy exposes Schlemm canal and its valveless collector channels to the anterior chamber; the hyphema was self-limited in all affected eyes. This complication of
Table 5. Complications and repeat interventions. Number (%) Finding Hyphema* Flat bleb* Filtering bleb* Descemet membrane detachment IOP elevation O20 mm Hg Corneal edema Fibrin exudation Shallow anterior chamber
Phaco-Viscosynechiolysis
Phacotrabeculectomy
26 (86.66) 27 (90) 3 (10) 6 (20) 3 (10) 2 (6.7) 1 (3.3) 1 (3.3)
3 (10.34) 5 (17.24) 24 (82.76) 2 (6.9) 5 (17.24) 3 (10.34) 2 (6.9) 1 (3.45)
IOP Z intraocular pressure *Statistically significant
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PHACO–VISCOSYNECHIALYSIS–TRABECULOTOMY VS PHACOTRABECULOTOMY IN PACG
synechialysis has been previously reported.28 There were a few cases of fibrosis or scarred flat blebs in the phacotrabeculectomy group, which is in accordance with findings in other studies.31 Although phaco–synechialysis is not primarily a filtering procedure, a bleb formed in a few eyes in that group. We hypothesize that defective closure of the scleral flap might have been the underlying cause. Finally, the occurrence of a limited Descemet membrane detachment with ab externo trabeculotomy parallels results in previous reports.17 The current study has limitations. The relatively small number of eyes included precludes robust generalization of the our results. Performing synechialysis with the use of intraoperative gonioscopy would have allowed a more controlled procedure under direct visualization. The lack of preoperative anterior segment imaging to objectively assess the extent of PAS and the configuration of the anterior chamber angle is another issue. However, this limitation was offset by the assessment of the study cases by an experienced consultant (A.S.E.). That the study eyes had a peripheral iridotomy/iridectomy might have affected some outcomes, such as the preoperative assessment of the angle configuration and the ACD findings on ultrasound biomicroscopy and might have affected the IOP outcomes. In conclusion, both phacoemulsification–viscosynechialysis–trabeculotomy and phacotrabeculectomy were relatively safe and effective in reducing the IOP in eyes with PACG for at least 2 years, with phaco–viscosynechialysis–trabeculotomy being more advantageous than phacotrabeculectomy.
WHAT WAS KNOWN Lens extraction increases the depth of the anterior chamber and the width of the angle and helps lower the intraocular pressure (IOP) in eyes with primary angle-closure glaucoma (PACG). Phacotrabeculectomy reduces the IOP in eyes with chronic PACG.
WHAT THIS PAPER ADDS Viscosynechialysis combined with phacoemulsification and trabeculotomy yielded a greater reduction in the IOP than phacotrabeculectomy in eyes with chronic PACG and visually significant cataract.
REFERENCES 1. Liu S-A, Zhao Z-N, Sun N-N, Han Y, Chen J, Fan Z-G. Transitions of the understanding and definition of primary glaucoma. Chin Med J (Engl) 2018; 131:2852–2859 2. Bordeianu CD. [Criticism of the gonioscopic classifications of the glaucoma: with particular reference to the classification issued by the European Glaucoma Society in 2008]. [Romanian]. Oftalmologia 2014; 58 (3):7–22 3. Wright C, Tawfik MA, Waisbourd M, Katz LJ. Primary angle-closure glaucoma: an update. Acta Ophthalmol 2016; 94:217–225 4. Tham Y-C, Li X, Wong TY, Quigley HA, Aung T, Cheng C-Y. Global prevalence of glaucoma and projections of glaucoma burden through 2040; a systematic review and meta-analysis. Ophthalmology 2014; 121:2081– 2090
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5. Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol 2002; 86:238–242 6. He M, Jiang Y, Huang S, Chang DS, Munoz B, Aung T, Foster PJ, Friedman DS. Laser peripheral iridotomy for the prevention of angle closure: A single-centre, randomised controlled trial. Lancet 2019; 393:1609–1618 7. Rao A, Rao HL, Kumar AU, Babu JG, Madhulata U, Arthi J, Tukaram M, Senthil S, Garudadri CS. Outcomes of laser peripheral iridotomy in angle closure disease. Semin Ophthalmol 2013; 28:4–8 8. Pillunat KR, Spoerl E, Orphal J, Pillunat LE. Argon laser peripheral iridoplasty for chronic primary angle-closure and angle-closure glaucoma in caucasians. Acta Ophthalmol 2019; 97:e225–e230 9. Rao A, Rao HL, Senthil S, Garudadri CS. Varied clinical course in plateau iris syndrome: a case series. Semin Ophthalmol 2013; 28:28–31 10. Aung T, Wong HT, Yip CC, Leong JYN, Chan Y-H, Chew PTK. Comparison of the intraocular pressure-lowering effect of latanoprost and timolol in patients with chronic angle closure glaucoma; a preliminary study. Ophthalmology 2000; 107:1178–1183 11. Kim JM, Park KH, Kim CY, Kim HK, Kim T-W, Kim MS. Effects of brimonidine timolol fixed combination therapy on anterior ocular segment configuration. Jpn J Ophthalmol 2011; 55:356–361 12. Bevin TH, Molteno ACB, Herbison P. Otago Glaucoma Surgery Outcome Study: long-term results of 841 trabeculectomies. Clin Exp Ophthalmol 2008; 36:731–737 13. Ng WT, Morgan W. Mechanisms and treatment of primary angle closure: a review. Clin Exp Ophthalmol 2012; 40:e218–e228 14. Tham CCY, Kwong YYY, Baig N, Leung DYL, Li FCH, Lam DSC. Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology 2013; 120:62– 67 15. Azuara-Blanco A, Burr J, Ramsay C, Cooper D, Foster PJ, Friedman DS, Scotland G, Javanbakht M, Cochrane C, Norrie J, for the EAGLE study group. Effectiveness of early lens extraction for the treatment of primary angle-closure glaucoma (EAGLE): a randomised controlled trial. Lancet 2016; 388:1389–1397 16. Zhang H, Tang G, Liu J. Effects of phacoemulsification combined with goniosynechialysis on primary angle-closure glaucoma. J Glaucoma 2016; 25:e499–e503 17. Kiuchi Y, Tsujino C, Nakamura T, Otori Y, Mochizuki H. Phacoemulsification and trabeculotomy combined with goniosynechialysis for uncontrollable chronic angle-closure glaucoma. Ophthalmic Surg Lasers Imaging 2010; 41:348–354 18. Liang Y, Friedman DS, Zhou Q, Yang XH, Sun LP, Guo L, Chang DS, Lian L, Wang NL. for the Handan Eye Study Group. Prevalence and characteristics of primary angle-closure diseases in a rural adult Chinese population: the Handan eye study. Invest Ophthalmol Vis Sci 2011; 52:8672–8679 19. He M, Foster PJ, Johnson GJ, Khaw PT. Angle-closure glaucoma in East Asian and European people. Different diseases? Eye 2006; 20:3–12 20. Day AC, Baio G, Gazzard G, Bunce C, Azuara-Blanco A, Munoz B, Friedman DS, Foster PJ. The prevalence of primary angle closure glaucoma in European derived populations: a systematic review. Br J Ophthalmol 2012; 96:1162–1167 21. Song BJ, Ramanathan M, Morales E, Law SK, Giaconi JA, Coleman AL, Caprioli J. Trabeculectomy and combined phacoemulsificationtrabeculectomy: outcomes and risk factors for failure in primary angle closure glaucoma. J Glaucoma 2016; 25:763–769 22. Chan PP, Li EY, Tsoi KKF, Kwong YY, Tham CC. Cost-effectiveness of phacoemulsification versus combined phacotrabeculectomy for treating primary angle closure glaucoma. J Glaucoma 2017; 26:911–922 23. Nongpiur ME, He M, Amerasinghe N, Friedman DS, Tay W-T, Baskaran M, Smith SD, Wong TY, Aung T. Lens vault, thickness, and position in Chinese subjects with angle closure. Ophthalmology 2011; 118:474–479 24. Winegarner A, Miki A, Kumoi M, Ishida Y, Wakabayashi T, Sakimoto S, Usui S, Matsushita K, Nishida K. Anterior segment Scheimpflug for detecting primary angle closure disease. Graefes Arch Clin Exp Ophthalmol 2019; 257:161–167 25. Tham CCY, Kwong YYY, Leung DYL, Lam SW, Li FCH, Chiu TYH, Chan JCH, Lam DSC, Lai JSM. Phacoemulsification versus combined phacotrabeculectomy in medically uncontrolled chronic angle closure glaucoma with cataracts. Ophthalmology 2009; 116:725–731 26. Zhang X, Teng L, Li A, Du S, Zhu Y, Ge J. The clinical outcomes of three surgical managements on primary angle-closure glaucoma. Yan Ke Xue Bao 2007; 23:65–74 27. Rodrigues IA, Alaghband P, Beltran Agullo L, Galvis E, Jones S, Husain R, Lim KS. Aqueous outflow facility after phacoemulsification with or without goniosynechialysis in primary angle closure: a randomised controlled study. Br J Ophthalmol 2017; 101:879–885
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28. Zhao X-j, Yang X-x, Fan Y-p, Li B-h, Li Q. Comparison of combined phacoemulsification, intraocular lens implantation, and goniosynechialysis with Phacotrabeculectomy in the treatment of primary angle-closure glaucoma and cataract. Asia Pac J Ophthalmol 2013; 2:286–290 29. Bojikian KD, Chen PP. Intraocular pressure after phacoemulsification in open-angle glaucoma patients with uncontrolled or marginally controlled glaucoma and/or with severe visual field loss. J Glaucoma 2018; 27:108–114 30. Seol BR, Jeoung JW, Park KH. Changes of visual-field global indices after cataract surgery in primary open-angle glaucoma patients. Jpn J Ophthalmol 2016; 60:439–445 31. Koh V, Chen D, Aquino CM, Aduan J, Sng C, Chee LS, Chew P. Success rates of 2-site phacoemulsification combined with fornix-based trabeculectomy using mitomycin C for primary angle-closure glaucoma and primary open-angle glaucoma in an Asian population. Jpn J Ophthalmol 2017; 61:245–252
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Disclosures: None of the authors has a financial or proprietary interest in any material or methods mentioned.
First author: Ahmed S. Elwehidy, MD, PhD Faculty of Medicine, Mansoura University, Egypt
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