- Email: [email protected]
Five-year results of deep sclerectomy with collagen implant
Five-year results of deep sclerectomy with collagen implant Tarek Shaarawy, MD, Marc Karlen, MD, Corinne Schnyder, MD, Farid Achache, MD, Enrique Sanchez, MD, Andre´ Mermoud, MD ABSTRACT Purpose: To study prospectively the success rate and complications of deep sclerectomy with collagen implant (DSCI), a nonpenetrating filtration procedure. Setting: Glaucoma Unit, Department of Ophthalmology, Hoˆpital Ophtalmique Jules Gonin, University of Lausanne, Lausanne, Switzerland. Methods: This nonrandomized prospective trial comprised 105 eyes of 105 patients with medically uncontrolled primary or secondary open-angle glaucoma. Visual acuity, intraocular pressure (IOP), and slitlamp examinations were performed before and after surgery at 1 and 7 days and 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, 54, 60, and 66 months. Visual field examinations were repeated every 6 months. A qualified success was defined as IOP below 21 mm Hg with or without medication. A complete success was defined as IOP lower than 21 mm Hg without medication. Results: The mean follow-up was 43.2 months ⫾ 14.3 (SD). The mean IOP was 26.8 ⫾ 7 mm Hg preoperatively, 5.1 ⫾ 3 mm Hg 1 day postoperatively, and 11.8 ⫾ 3 mm Hg 60 months postoperatively. At 60 months, the qualified success rate was 94.8% and the complete success rate, 61.9%. The IOP was lower than 21 mm Hg with medication in 32.1% of patients at 60 months; 48 patients (45.7%) had an IOP of 15 mm Hg or lower without medication. No patient developed a shallow or flat anterior chamber, endophthalmitis, or surgery-induced cataract. However, 23 (21.9%) had progression of a preexisting senile cataract. Injections of 5-fluorouracil were given to 25 patients (23.8%) who had DSCI to salvage encysted blebs. The mean number of medications per patient was reduced from 2.30 ⫾ 0.76 to 0.49 ⫾ 0.72. Conclusion: Deep sclerectomy with collagen implant provided reasonable IOP over a long-term follow-up with few immediate postoperative complications. J Cataract Refract Surg 2001; 27:1770 –1778 © 2001 ASCRS and ESCRS
D
eep sclerectomy with collagen implant (DSCI) is a nonpenetrating filtration procedure for the surgical treatment of medically uncontrolled open-angle Accepted for publication June 20, 2001. Reprint requests to Andre´ Mermoud, MD, Hoˆpital Ophtalmique Jules Gonin, Avenue de France 15, CH-1004 Lausanne, Switzerland. E-mail: [email protected]. © 2001 ASCRS and ESCRS Published by Elsevier Science Inc.
glaucoma. The more classic trabeculectomy, with or without antimetabolites, has a well-documented complication rate.1–12 The DSCI technique was designed to lower the risk of such complications, offering both surgeon and patient a safer, more convenient option.13 This prospective nonrandomized study included 105 patients who had DSCI between May 1994 and early 1996 and who were followed for 66 months. 0886-3350/01/$–see front matter PII S0886-3350(01)01032-X
DEEP SCLERECTOMY WITH COLLAGEN IMPLANT
Patients and Methods One hundred five eyes of 105 white patients (Table 1) with medically uncontrolled primary or secondary open-angle glaucoma had DSCI. The patients were enrolled consecutively after the approval of the Ethical Committee of the University of Lausanne. Informed consent was obtained from all participants. Patients selected were medically uncontrolled with maximum medical therapy. Uncontrolled glaucoma was defined as an intraocular pressure (IOP) greater than 21 mm Hg measured with a Goldmann applanation tonometer under maximum tolerable medical treatment (2 or more antiglaucoma medications) and with well-documented progression of visual field defects and optic nerve morphology. Exclusion criteria were an unwillingness to participate, one-eyed patients, known allergy to collagen, advanced lens opacities, and eye surgery or laser Table 1. Characteristics of patients. Characteristic Number of patients Mean age (years) ⫾ SD Men/women White/black
Result 105 75 ⫾ 13.1 46/59 105/0
Preop IOP (mm Hg) Mean ⫾ SD Range Mean preop meds
26.8 ⫾ 7.7 19–50 2.3 ⫾ 0.7
Number of postop meds, n (%) 2
64 (62)
3
35 (33)
4
6 (5)
Diagnosis, n POAG
56
PEXG
26
PSPHG
14
NPG
5
Aphakia
2
Other
5
IOP ⫽ intraocular pressure; meds ⫽ medications; n ⫽ number of patients; POAG ⫽ primary open-angle glaucoma; PEXG ⫽ pseudoexfoliative glaucoma; PSPHG ⫽ pseudophakic glaucoma; NPG ⫽ normal tension glaucoma; Aphakia ⫽ aphakic glaucoma
trabeculoplasty fewer than 6 months before enrollment in the study. All patients in the series had bilateral glaucomatous visual field defects. On the day before surgery, patients had an examination including best corrected visual acuity (BCVA) assessment (Snellen chart at 5 meters) and IOP measurement using a Haag-Streit Goldmann applanation tonometer mounted on a slitlamp. Patients also had biomicroscopy, gonioscopy, visual field testing using the G1 program of the Octopus 101 (Interzeag AG), and fundus biomicroscopy. Postoperative evaluation, which included all preoperative examinations except for visual field assessment, was done at 1 and 7 days and 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, 54, 60, and 66 months. Anterior chamber depth was clinically assessed in comparison with that in the fellow eye. A visual field examination was done every 6 months. If complications occurred, follow-up was more frequent. Complications were defined as follows: hyphema, erythrocytes in the anterior chamber; hypotony, a postoperative IOP of 4 mm Hg for more than 2 weeks; shallow anterior chamber, iris– cornea touch in the periphery; flat anterior chamber, lens– cornea touch seen on biomicroscopy; anterior chamber inflammation, flare seen on biomicroscopy; choroidal detachment, seen in the peripheral retina by indirect ophthalmoscopy. In the postoperative follow-up, cataracts that were a direct consequence of filtration surgery were considered surgery related. Those that appeared progressively were termed cataract progression. Surgeryrelated cataract was defined by a rapid decrease (1 month) in visual acuity and mainly the development of cortical opacity. Cataract progression was defined as a slow, progressive decrease in visual acuity of more than 2 Snellen lines as a result of lens opacification, mainly nuclear sclerosis. Surgical Technique All surgeries were performed by 1 experienced surgeon (A.M.) using retrobulbar anesthesia comprising 2 to 4 mL of bupivacaine 0.75%, lidocaine hydrochloride 4% (Xylocaine威), and hyaluronidase 50 U. A superior rectus muscle suture was placed. After the conjunctiva and Tenon’s capsule were opened in the upper fornix, the sclera was exposed and hemostasis by wet-field cautery performed.
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Figure 1. (Shaarawy) A one-third scleral thickness, limbal-based
Figure 2. (Shaarawy) A rectangle of deeper scleral tissue is
scleral flap is dissected.
dissected.
A one-third scleral thickness, limbal-based, 5.0 mm ⫻ 5.0 mm scleral flap was dissected (Figure 1) and then further dissected 1.0 mm into clear cornea. A triangle or a rectangle of deep sclera was removed (Figure 2), leaving a thin layer of deep sclera over the choroid posteriorly. Anteriorly, the dissection was to Schlemm’s canal, which was unroofed, and the excision of corneal stroma to the level of Descemet’s membrane (Figure 3). Aqueous humor began percolating through the remaining thin trabeculo-Descemet’s membrane (TDM). A cylindrical collagen implant drainage device (Staar Surgical) measuring 1.0 mm ⫻ 1.0 mm ⫻ 2.5 mm (Figure 4) was placed radially in the center of the deep sclerectomy dissection and secured with a single 10-0 nylon suture to the thin remnant scleral layer,
posterior to Schlemm’s canal (Figures 5 and 6). The collagen implant has been described.14 The superficial scleral flap was repositioned over the implant and secured with 2 single 10-0 nylon sutures; the knots were buried. No tension was applied to the 2 sutures as the aqueous outflow resistance was at the TDM. The conjunctiva and Tenon’s capsule were closed with a running 8-0 polyglactin (Vicryl威) suture. Postoperatively, patients were treated with topical neomycin 0.35%, polymyxin 6000 IU/mL, and dexamethasone 0.1% (Maxitrol威) 3 times a day for 2 weeks and then with topical fluoromethonolum 1 mg, 3 times a day for 3 to 6 months. If the IOP increased, the fluoromethonolum was replaced by topical nonsteroidal antiinflammatory eyedrops.
Figure 3. (Shaarawy) The rectangle is removed, leaving a thin layer
Figure 4. (Shaarawy) The collagen implant is 2.5 mm in length and 1.0 mm in diameter.
of deep sclera, an unroofed Schlemm’s canal, and Descemet’s membrane.
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Figure 5. (Shaarawy) The collagen implant is placed radially and secured with a single 10-0 nylon suture.
Figure 6. (Shaarawy) The collagen implant is placed after deep
When the TDM perforated during corneal stroma dissection, the surgery was converted to a standard trabeculectomy. A rectangular resection of the trabeculum and basal iridectomy were performed. Microperforations may have occurred in some cases but were difficult to identify. The results in 6 patients who had perforation of the TDM are not analyzed here as they have been reported.15 Surgery was considered a complete success when IOP was 21 mm Hg without glaucoma medication and a qualified success when 21 mm Hg with medication. It was a failure when IOP was greater than 21 mm Hg with or without medication or when an eye required further glaucoma drainage surgery, developed phthisis bulbi, or lost light perception. The IOP was measured 3 times, once every 5 minutes over 15 minutes, and a mean calculated. When the mean was greater than 21 mm Hg, surgery was considered a failure. When the filtering bleb was encysted or showed signs of fibrosis postoperatively, subconjunctival injections of 5 mg of 5-fluorouracil (5-FU) were administered in the lower quadrant, opposite the DSCI. The subconjunctival injections consisted of 0.1 mL of a 50 mg/mL solution of 5-FU (250 mg/5 mL FluoroUracil威). The injections were repeated up to 7 times. Goniopuncture with a Microruptor II neodymium: YAG (Nd:YAG) laser (Lasag AG) was performed when filtration through the TDM seemed insufficient because
of a shallow filtration bleb or elevated IOP. The goal was to create a small hole in the TDM, allowing direct passage of aqueous humor from the anterior chamber to the filtration bleb and transforming nonperforating filtering into perforating surgery. A Lasag-15 gonioscopy contact lens (CGA1) and Q-switch mode were used, with energy ranging from 2 to 4 mJ. After treatment, patients received topical prednisolone acetate (Predforte威) 3 times a day for 3 days. Laser goniopuncture was considered a success when the final IOP was less than 18 mm Hg or when IOP decreased more than 5 mm Hg with an initial pressure of 23 mm Hg.
sclerectomy dissection. Schlemm’s canal is unroofed, the anterior trabeculum and Descemet’s membrane are exposed, and aqueous is seen filtering through the remaining membrane.
Data Collection The clinical information from the patients’ records was computerized in 1996 to facilitate data collection and analysis. A format was devised using Microsoft Excel to collect and analyze clinical information from the patients’ records. Data from 1994 to 1996, including preoperative clinical findings, surgical procedure, postoperative behavior, and subsequent outpatient visits, were entered into the database retrospectively and thereafter prospectively. Statistical Analysis Results were analyzed using the Student t test for comparison of means, a chi-square analysis for 2 ⫻ 2 tables, and Kaplan-Meier survival curves for long-term
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Figure 7. (Shaarawy) Intraocular pressure before and after DSCI (D ⫽ days; W ⫽ weeks; M ⫽ months).
success rate analysis. The Wilcoxon test was used for between-group comparisons.
Results The mean follow-up was 43.2 months ⫾ 14.3 (SD) (range 18 to 66 months). Sixty patients completed 60 months, and 6 were lost to follow-up after a minimum of 18 months. The mean IOP was 26.8 mm Hg preoperatively and 5.1 mm Hg 1 day postoperatively. The mean IOP at 3 months was 12.2 ⫾ 3.4 mm Hg, a reduction from preoperatively of 55.5%, and at 48 months, 12.24 ⫾ 4.6 mm Hg, a reduction of 55.4%. Thus, IOP was stable postoperatively (Figure 7). All patients had a shallow, diffuse subconjunctival bleb. At 60 months, the complete success rate (IOP ⬍ 21 mm Hg without medication) was 61.9% (Figure 8) and the qualified success rate (IOP ⬍ 21 mm Hg with or without medication), 94.8%. The IOP was lower than 21 mm Hg with medication in 32.3% of patients. The mean number of medications per patient, which was 2.30 ⫾ 0.76 preoperatively, was 0.49 ⫾ 0.72 after DSCI. Of patients having an IOP less than 21 mm Hg without treatment, 6 (9.2%) had an IOP between 19 and 21 mm Hg, 11 (16.9%) between 16 and 18 mm Hg, and 48 (73.8%; 45.7% of entire series) of 15 mm Hg or less. Of patients with an IOP less than 21 mm Hg with treatment, 6 (17.6%) had an IOP 1774
Figure 8. (Shaarawy) Long-term cumulative complete success of DSCI (Kaplan-Meier life-table analysis).
between 19 and 21 mm Hg, 7 (20.5%) between 16 and 18 mm Hg, and 21 (61.7%) of 15 mm Hg or less. Of the 105 eyes having DSCI, IOP was uncontrolled (mean 26.6 mm Hg) in 6 cases (5.7%), which required a reoperation (trabeculectomy or another DSCI with intraoperative mitomycin-C). The mean BCVA, which was 0.73 preoperatively, was 0.53 1 day postoperatively. Visual acuity returned to preoperative levels 1 week after surgery and remained stable over the next 5.5 years; the mean was 0.72 at 48 months and 0.73 at 66 months (Figure 9). The mean defect was 12.72 preoperatively, 11.09 at 12 months, and 8.16 at 60 months. The mean corrected lost vari-
Figure 9. (Shaarawy) Mean BCVA before and after DSCI (D ⫽ days; W ⫽ weeks; M ⫽ months).
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ance was 47.2 preoperatively, 52.19 at 12 months, and 43.98 at 60 months. According to the Brusini glaucoma staging system,16 81% of patients in the complete success group maintained stable visual fields (within the same preoperative stage) and 19% had deterioration despite an IOP of 15 mm Hg or less, pointing to pressure-independent factors. There were no significant intraoperative complications. Figure 10 shows the postoperative complications. No patient developed a shallow or flat anterior chamber, bleb-related endophthalmitis, or surgery-induced cataract. Progression of a preexisting senile cataract occurred in 23 patients (21.9%). Twenty-five patients (23.8%) required 5-FU injections. The mean number of injections was 2.9 ⫾ 1.9 and the mean time between surgery and injection, 1.8 ⫾ 2.6 months. An Nd:YAG laser goniopuncture was performed in 48 patients (45.7%). The mean time between the goniopuncture and DSCI was 13.5 ⫾ 13.0 months. The mean IOP before goniopuncture was 20.6 ⫾ 6.0 mm Hg and after goniopuncture, 10.7 ⫾ 6.3 mm Hg. The difference was statistically significant (P ⬍ .001). The immediate success rate (IOP ⬍ 18 mm Hg or IOP decrease ⬍ 5 mm Hg with initial pressure 23 mm Hg) was 91.6%. Over a mean follow-up of 45 ⫾ 16.0 months, the complete success rate in the subgroup of 48 patients requiring goniopuncture was 60.4% (29 patients) and the qualified success rate, 87.5% (42 patients).
Figure 10. (Shaarawy) Postoperative complications (A ⫽ 5-FU injections; B ⫽ cataract progression; C ⫽ bleb encapsulation; D ⫽ bleb fibrosis; E ⫽ hyphema; F ⫽ wound leak; G ⫽ choroidal detachment; H ⫽ Dellen; I ⫽ needling; K ⫽ malignant glaucoma; L ⫽ hypotony).
Discussion Classic glaucoma teachings consider surgery to be a last resort for the treatment of primary open-angle glaucoma after topical therapy and argon laser trabeculoplasty (ALT) have failed to control IOP.17 However, recent data from the Advanced Glaucoma Intervention Study18 show a race-related response to ALT, which argues for trabeculectomy before ALT in white patients. Such data are clearly at odds with the classic approach of surgery as a last-stage intervention. Most surgeons prefer to delay surgery because of the potential vision-threatening complications of standard trabeculectomy performed with or without antimetabolites. Complications include hypotony, hyphema, a flat anterior chamber, choroidal effusion or hemorrhage, surgery-induced cataract, and bleb failure.1–12 However, surgery is an effective way to lower IOP. Bylsma17 hypothesizes that if the safety margin of glaucoma surgery could be increased significantly without sacrificing efficacy, surgical intervention for glaucoma might be considered earlier. To avoid the postoperative complications of trabeculectomy (Table 2), some authors propose tightly closing the scleral flap with secondary suturelysis using an argon laser.19 More recently, Zimmerman et al.20,21 reported favorable results of nonpenetrating trabeculectomy in phakic and aphakic patients. Stegmann and coauthors22 describe a similar technique in which the scleral space is filled with viscoelastic substance. They report a complete success of rate of 82.7% and a qualified success rate of 89.0% over a 35-month follow-up. Kozlov et al.13 and Fyodorov23 describe placing a collagen implant in the scleral bed to enhance the filtration of deep sclerectomy. Sanchez and coauthors15 report a better surgical outcome when the collagen implant is used. Chiou et al.24,25 report ultrasonic biomicroscopy findings consistent with IOP lowering by aqueous filtration through the thin remaining TDM to an area under the scleral flap, which was hypothetically kept open by the presence of the collagen implant. Other available implants are the reticulated hyaluronic acid implant26 and the hydrophilic acrylic nonabsorbable implant (E. Dahan, MD, personal communication, February 2001). The DSCI technique prevents sudden hypotony after trabeculectomy by creating progressive filtration of
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Table 2. Postoperative complications of trabeculectomy in the literature compared with those in the current study. Complication (%) Study* Current 11
Molteno
Number of Eyes
Hyphema
105
8.5
Hypotony
Shallow AC
Choroid Detach
Further Surgery
0.9
0
6.6
5.7
Uveitis 0
Cataract Progress 0
Endoph 0
289
8.0
NAD
6.0
10.7
4.8
NAD
NAD
NAD
66
53.0
NAD
11.6
NAD
NAD
4.5
9.8
NAD
1
387
22.0
5.0
16.0
NAD
NAD
2.0
14.2
0
1
112
40.0
25.0
28.0
NAD
NAD
5.0
NAD
0
Akafo
81
NAD
NAD
NAD
NAD
6.1
NAD
NAD
1.2
D’Ermo12
90
8.7
NAD
NAD
4.4
NAD
NAD
2.2
NAD
444
6.9
NAD
13.1
5.3
6.2
0.8
NAD
0.5
Zaidi8 Watson Watson 9
Mills10
AC ⫽ anterior chamber; Choroid Detach ⫽ choroidal detachment; Progress ⫽ progression; Endoph ⫽ endophthalmitis; NAD ⫽ no available data *First author listed only
aqueous humor from the anterior chamber to the subconjunctival space without perforating the eye. In an experimental model, Vaudaux and coauthors27 studied the aqueous dynamics through the remaining thin TDM membrane and found that the outflow resistance was low but sufficient to prevent the immediate postoperative complications of trabeculectomy. The short-term success of DSCI has been reported to be favorable. Demailly et al.28,29 report a mean decrease in IOP of 9.1 ⫾ 7.1 mm Hg after 219 DSCI procedures. The success rate without glaucoma medication was 89% at 6 months and 75.6% at 16 months. With medication, it was 97% and 79%, respectively. Kozlov et al.30 report an 85% success rate but gave no information on success criteria or follow-up. Karlen et al.31 report a complete success rate of 44.6% and a qualified success rate of 97.7% at 36 months. In our study, except for the first week after surgery, visual acuity was unaffected by DSCI. This may be because the eye was not perforated, preventing inflammation, mydriatics use, and sudden hypotony. Furthermore, visual acuity remained stable because no surgeryrelated cataracts developed. The major intraoperative complication was perforation of the thin TDM during the deep sclerectomy dissection. This was common in the learning phase of deep sclerectomy, occurring in 3 of the first 10 surgeries (30.0%). The complication rate sharply decreased as surgical experience increased; only 3 of the subsequent 101 deep sclerectomies (2.9%) resulted in perforation. The postoperative complications and final outcome 1776
in the 6 patients with intraoperative perforation of the TDM15 were similar to those in patients who had standard trabeculectomy. The early postoperative complications included the presence of subtle hyphema (unleveled) in 8.5% of cases. The small amount of blood in the anterior chamber was likely blood reflux from the scleral bed through the anterior trabeculum or through undetected microperforations. Twenty-three percent of patients required subconjunctival 5-FU injections for fibrotic or encysted blebs. The mean number of injections per patient (2.9 ⫾ 1.9) was significantly lower than in previous studies using 5-FU after trabeculectomy (7 to 21 injections).32 Most injections were administered during the first 2 months postoperatively. One patient developed malignant glaucoma on the first postoperative day. It was successfully treated with scopolamine. Forty-six percent of patients required an Nd:YAG goniopuncture. Goniopunctures were performed shortly after DSCI when there was insufficient percolation of aqueous humor at the TDM, probably due to the lack of surgical dissection. Goniopunctures performed more than 9 months after surgery were for low filtration, which was probably the result of fibrosis of the TDM because the goniopuncture increased aqueous humor filtration and decreased IOP. The success rate of Nd:YAG laser goniopuncture was satisfactory, with an immediate reduction in mean IOP of 48.1%. By opening the TDM, however, goniopuncture transformed a nonper-
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forating filtration procedure into a perforating one. Although the potential risk of late bleb-related endophthalmitis may increase after goniopuncture, no cases occurred during the study. Others report Nd:YAG goniopuncture success rates between 68% and 94%.29,30,33 These results compare favorably with our success rate of 91.6%. In a prospective comparative study of DSCI and standard trabeculectomy in patients with open-angle glaucoma,34 69% in the DSCI group and 57% in the trabeculectomy group had an IOP lower than 21.0 mm Hg without medication at 24 months. The complication rate was significantly lower in the DSCI group. The authors conclude that the success rate of DSCI might be comparable to that of trabeculectomy, with fewer complications. Chiou and coauthors35 report statistically significantly lower flare measurements after DSCI than after trabeculectomy. This may be the result of the lack of iridectomy, irrigation, and anterior chamber penetration with DSCI. In conclusion, DSCI appears to be a promising new nonperforating filtration procedure. In our study, the success rate after 5.5 years of follow-up was satisfactory for all types of primary and secondary open-angle glaucoma studied. The immediate postoperative complication rate was low, and visual acuity was not significantly affected.
References 1. Watson PG, Jakeman C, Ozturk M, et al. The complications of trabeculectomy (a 20-year follow-up). Eye 1990; 4:425– 438 2. Kao SF, Lichter PR, Musch DC. Anterior chamber depth following filtration surgery. Ophthalmic Surg 1989; 20: 332–336 3. Stewart WC, Shields MB. Management of anterior chamber depth after trabeculectomy. Am J Ophthalmol 1988; 106:41– 44 4. Brubaker RF, Pederson JE. Ciliochoroidal detachment. Surv Ophthalmol 1983; 27:281–289 5. Gressel MG, Parrish RK II, Heuer DK. Delayed nonexpulsive suprachoroidal hemorrhage. Arch Ophthalmol 1984; 102:1757–1760 6. Ruderman JM, Harbin TS Jr, Campbell DG. Postoperative suprachoroidal hemorrhage following filtration procedures. Arch Ophthalmol 1986; 104:201–205 7. Freedman J, Gupta M, Bunke A. Endophthalmitis after trabeculectomy. Arch Ophthalmol 1978; 96:1017–1018
8. Zaidi AA. Trabeculectomy: a review and 4-year followup. Br J Ophthalmol 1980; 64:436 – 439 9. Akafo SK, Goulstine DB, Rosenthal AR. Long-term post trabeculectomy intraocular pressures. Acta Ophthalmol 1992; 70:312–316 10. Mills KB. Trabeculectomy: a retrospective long-term follow-up of 444 cases. Br J Ophthalmol 1981; 65:790 –795 11. Molteno ACB, Bosma NJ, Kittelson JM. Otago glaucoma surgery outcome study: long-term results of trabeculectomy—1976 to 1995. Ophthalmology 1999; 106:1742–1750 12. D’Ermo F, Bonomi L, Doro D. A critical analysis of the long-term results of trabeculectomy. Am J Ophthalmol 1979; 88:829 – 835 13. Kozlov VI, Bagrov SN, Anisimova SY, et al. [Deep sclerectomy with collagen]. [Russian] Eye Microsurgery 1990; 3:44 – 46 14. Hamel M, Shaaraway T, Mermoud A. Deep sclerectomy with collagen implant in patients with glaucoma and high myopia. J Cataract Refract Surg 2001; 27:1410 –1417 15. Sanchez E, Schnyder CC, Mermoud A. Re´sultats comparatifs de la scle´rectomie profonde transforme´e en trabe´culectomie et de la trabe´culectomie classique. Klin Monatsbl Augenheilkd 1997; 210:261–264 16. Brusini P. Clinical use of a new method for visual field damage classification in glaucoma. Eur J Ophthalmol 1996; 6:402– 407 17. Bylsma S. Nonpenetrating deep sclerectomy: collagen implant and viscocanalostomy procedures. Int Ophthalmol Clin 1999; 39(3):103–119 18. The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS). 4. Comparison of treatment outcomes within race; seven-year results. Ophthalmology 1998; 105:1146 –1164 19. Savage JA, Condon GP, Lytle RA, Simmons RJ. Laser suture lysis after trabeculectomy. Ophthalmology 1988; 95:1631–1637; discussion by AE Kolker, 1637 20. Zimmerman TJ, Kooner KS, Ford VJ, et al. Trabeculectomy vs. nonpenetrating trabeculectomy: a retrospective study of two procedures in phakic patients with glaucoma. Ophthalmic Surg 1984; 15:734 –740 21. Zimmerman TJ, Kooner KS, Ford VJ, et al. Effectiveness of nonpenetrating trabeculectomy in aphakic patients with glaucoma. Ophthalmic Surg 1984; 15:44 –50 22. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg 1999; 25:316 –322 23. Fyodorov, SN. [Non penetrating deep sclerectomy in open-angle glaucoma]. [Russian] Eye Microsurgery 1989; 2:52–55 24. Chiou AG-Y, Mermoud A, Underdahl JP, Schnyder CC. An ultrasound biomicroscopic study of eyes after deep sclerectomy with collagen implant. Ophthalmology 1998; 105:746 –750
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25. Chiou AG-Y, Mermoud A, He´diguer S-EA, et al. Ultrasound biomicroscopy of eyes undergoing deep sclerectomy with collagen implant. Br J Ophthalmol 1996; 80: 541–544 26. Sourdille P, Santiago P-Y, Villain F, et al. Reticulated hyaluronic acid implant in nonperforating trabecular surgery. J Cataract Refract Surg 1999; 25:332–339 27. Vaudaux J, Uffer S, Mermoud A. Aqueous dynamics after deep sclerectomy: in vitro study. Ophthalmic Pract 1998; 16:204 –209 28. Demailly P, Lavat P, Kretz G, Jeanteur-Lunel MN. Nonpenetrating deep sclerectomy (NPDS) with or without collagen device (CD) in primary open-angle glaucoma: middle-term retrospective study. Int Ophthalmol 1996/ 97; 20:131–140 29. Demailly P, Jeanteur-Lunel MN, Berkani M, et al. La scle´rectomie profonde non perforante associe´e a` la pose d’un implant de collage´ne dans le glaucome. J Fr Ophtalmol 1996; 19:659 – 666 30. Kozlov VI, Bagrov SN, Anisimova SY, et al. [Nonpenetrating deep sclerectomy with collagen]. [Russian] Eye Microsurgery 1990; 3:157–162 31. Karlen ME, Sanchez E, Schnyder CC, et al. Deep sclerectomy with collagen implant: medium term results. Br J Ophthalmol 1999; 83:6 –11
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32. The Fluorouracil Filtering Surgery Study Group. Fluorouracil filtering surgery study one-year follow-up. Am J Ophthalmol 1989; 108:625–35 33. Mermoud A, Karlen M-E, Schnyder CC, et al. Nd:YAG goniopuncture after deep sclerectomy with collagen implant. Ophthalmic Surg Lasers 1999; 30:120 –5 34. Mermoud A, Schnyder CC, Sickenberg M, et al. Comparison of deep sclerectomy with collagen implant and trabeculectomy in open-angle glaucoma. J Cataract Refract Surg 1999; 25:323–331 35. Chiou AG-Y, Mermoud A, Jewelewicz DA. Post-operative inflammation following deep sclerectomy with collagen implant versus standard trabeculectomy. Graefes Arch Clin Exp Ophthalmol 1998; 236:593– 596
From Hoˆpital Ophtalmique Jules Gonin, Department of Ophthalmology, University of Lausanne, Lausanne, Switzerland (Shaarawy, Karlen, Schnyder, Achache, Sanchez, Andre´ Mermoud), and the Glaucoma Unit, Memorial Research Institute of Ophthalmology, Giza, Egypt (Shaarawy). Presented at the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, May 2000.
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eep sclerectomy with collagen implant (DSCI) is a nonpenetrating filtration procedure for the surgical treatment of medically uncontrolled open-angle Accepted for publication June 20, 2001. Reprint requests to Andre´ Mermoud, MD, Hoˆpital Ophtalmique Jules Gonin, Avenue de France 15, CH-1004 Lausanne, Switzerland. E-mail: [email protected]. © 2001 ASCRS and ESCRS Published by Elsevier Science Inc.
glaucoma. The more classic trabeculectomy, with or without antimetabolites, has a well-documented complication rate.1–12 The DSCI technique was designed to lower the risk of such complications, offering both surgeon and patient a safer, more convenient option.13 This prospective nonrandomized study included 105 patients who had DSCI between May 1994 and early 1996 and who were followed for 66 months. 0886-3350/01/$–see front matter PII S0886-3350(01)01032-X
DEEP SCLERECTOMY WITH COLLAGEN IMPLANT
Patients and Methods One hundred five eyes of 105 white patients (Table 1) with medically uncontrolled primary or secondary open-angle glaucoma had DSCI. The patients were enrolled consecutively after the approval of the Ethical Committee of the University of Lausanne. Informed consent was obtained from all participants. Patients selected were medically uncontrolled with maximum medical therapy. Uncontrolled glaucoma was defined as an intraocular pressure (IOP) greater than 21 mm Hg measured with a Goldmann applanation tonometer under maximum tolerable medical treatment (2 or more antiglaucoma medications) and with well-documented progression of visual field defects and optic nerve morphology. Exclusion criteria were an unwillingness to participate, one-eyed patients, known allergy to collagen, advanced lens opacities, and eye surgery or laser Table 1. Characteristics of patients. Characteristic Number of patients Mean age (years) ⫾ SD Men/women White/black
Result 105 75 ⫾ 13.1 46/59 105/0
Preop IOP (mm Hg) Mean ⫾ SD Range Mean preop meds
26.8 ⫾ 7.7 19–50 2.3 ⫾ 0.7
Number of postop meds, n (%) 2
64 (62)
3
35 (33)
4
6 (5)
Diagnosis, n POAG
56
PEXG
26
PSPHG
14
NPG
5
Aphakia
2
Other
5
IOP ⫽ intraocular pressure; meds ⫽ medications; n ⫽ number of patients; POAG ⫽ primary open-angle glaucoma; PEXG ⫽ pseudoexfoliative glaucoma; PSPHG ⫽ pseudophakic glaucoma; NPG ⫽ normal tension glaucoma; Aphakia ⫽ aphakic glaucoma
trabeculoplasty fewer than 6 months before enrollment in the study. All patients in the series had bilateral glaucomatous visual field defects. On the day before surgery, patients had an examination including best corrected visual acuity (BCVA) assessment (Snellen chart at 5 meters) and IOP measurement using a Haag-Streit Goldmann applanation tonometer mounted on a slitlamp. Patients also had biomicroscopy, gonioscopy, visual field testing using the G1 program of the Octopus 101 (Interzeag AG), and fundus biomicroscopy. Postoperative evaluation, which included all preoperative examinations except for visual field assessment, was done at 1 and 7 days and 1, 3, 6, 9, 12, 18, 24, 30, 36, 48, 54, 60, and 66 months. Anterior chamber depth was clinically assessed in comparison with that in the fellow eye. A visual field examination was done every 6 months. If complications occurred, follow-up was more frequent. Complications were defined as follows: hyphema, erythrocytes in the anterior chamber; hypotony, a postoperative IOP of 4 mm Hg for more than 2 weeks; shallow anterior chamber, iris– cornea touch in the periphery; flat anterior chamber, lens– cornea touch seen on biomicroscopy; anterior chamber inflammation, flare seen on biomicroscopy; choroidal detachment, seen in the peripheral retina by indirect ophthalmoscopy. In the postoperative follow-up, cataracts that were a direct consequence of filtration surgery were considered surgery related. Those that appeared progressively were termed cataract progression. Surgeryrelated cataract was defined by a rapid decrease (1 month) in visual acuity and mainly the development of cortical opacity. Cataract progression was defined as a slow, progressive decrease in visual acuity of more than 2 Snellen lines as a result of lens opacification, mainly nuclear sclerosis. Surgical Technique All surgeries were performed by 1 experienced surgeon (A.M.) using retrobulbar anesthesia comprising 2 to 4 mL of bupivacaine 0.75%, lidocaine hydrochloride 4% (Xylocaine威), and hyaluronidase 50 U. A superior rectus muscle suture was placed. After the conjunctiva and Tenon’s capsule were opened in the upper fornix, the sclera was exposed and hemostasis by wet-field cautery performed.
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Figure 1. (Shaarawy) A one-third scleral thickness, limbal-based
Figure 2. (Shaarawy) A rectangle of deeper scleral tissue is
scleral flap is dissected.
dissected.
A one-third scleral thickness, limbal-based, 5.0 mm ⫻ 5.0 mm scleral flap was dissected (Figure 1) and then further dissected 1.0 mm into clear cornea. A triangle or a rectangle of deep sclera was removed (Figure 2), leaving a thin layer of deep sclera over the choroid posteriorly. Anteriorly, the dissection was to Schlemm’s canal, which was unroofed, and the excision of corneal stroma to the level of Descemet’s membrane (Figure 3). Aqueous humor began percolating through the remaining thin trabeculo-Descemet’s membrane (TDM). A cylindrical collagen implant drainage device (Staar Surgical) measuring 1.0 mm ⫻ 1.0 mm ⫻ 2.5 mm (Figure 4) was placed radially in the center of the deep sclerectomy dissection and secured with a single 10-0 nylon suture to the thin remnant scleral layer,
posterior to Schlemm’s canal (Figures 5 and 6). The collagen implant has been described.14 The superficial scleral flap was repositioned over the implant and secured with 2 single 10-0 nylon sutures; the knots were buried. No tension was applied to the 2 sutures as the aqueous outflow resistance was at the TDM. The conjunctiva and Tenon’s capsule were closed with a running 8-0 polyglactin (Vicryl威) suture. Postoperatively, patients were treated with topical neomycin 0.35%, polymyxin 6000 IU/mL, and dexamethasone 0.1% (Maxitrol威) 3 times a day for 2 weeks and then with topical fluoromethonolum 1 mg, 3 times a day for 3 to 6 months. If the IOP increased, the fluoromethonolum was replaced by topical nonsteroidal antiinflammatory eyedrops.
Figure 3. (Shaarawy) The rectangle is removed, leaving a thin layer
Figure 4. (Shaarawy) The collagen implant is 2.5 mm in length and 1.0 mm in diameter.
of deep sclera, an unroofed Schlemm’s canal, and Descemet’s membrane.
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Figure 5. (Shaarawy) The collagen implant is placed radially and secured with a single 10-0 nylon suture.
Figure 6. (Shaarawy) The collagen implant is placed after deep
When the TDM perforated during corneal stroma dissection, the surgery was converted to a standard trabeculectomy. A rectangular resection of the trabeculum and basal iridectomy were performed. Microperforations may have occurred in some cases but were difficult to identify. The results in 6 patients who had perforation of the TDM are not analyzed here as they have been reported.15 Surgery was considered a complete success when IOP was 21 mm Hg without glaucoma medication and a qualified success when 21 mm Hg with medication. It was a failure when IOP was greater than 21 mm Hg with or without medication or when an eye required further glaucoma drainage surgery, developed phthisis bulbi, or lost light perception. The IOP was measured 3 times, once every 5 minutes over 15 minutes, and a mean calculated. When the mean was greater than 21 mm Hg, surgery was considered a failure. When the filtering bleb was encysted or showed signs of fibrosis postoperatively, subconjunctival injections of 5 mg of 5-fluorouracil (5-FU) were administered in the lower quadrant, opposite the DSCI. The subconjunctival injections consisted of 0.1 mL of a 50 mg/mL solution of 5-FU (250 mg/5 mL FluoroUracil威). The injections were repeated up to 7 times. Goniopuncture with a Microruptor II neodymium: YAG (Nd:YAG) laser (Lasag AG) was performed when filtration through the TDM seemed insufficient because
of a shallow filtration bleb or elevated IOP. The goal was to create a small hole in the TDM, allowing direct passage of aqueous humor from the anterior chamber to the filtration bleb and transforming nonperforating filtering into perforating surgery. A Lasag-15 gonioscopy contact lens (CGA1) and Q-switch mode were used, with energy ranging from 2 to 4 mJ. After treatment, patients received topical prednisolone acetate (Predforte威) 3 times a day for 3 days. Laser goniopuncture was considered a success when the final IOP was less than 18 mm Hg or when IOP decreased more than 5 mm Hg with an initial pressure of 23 mm Hg.
sclerectomy dissection. Schlemm’s canal is unroofed, the anterior trabeculum and Descemet’s membrane are exposed, and aqueous is seen filtering through the remaining membrane.
Data Collection The clinical information from the patients’ records was computerized in 1996 to facilitate data collection and analysis. A format was devised using Microsoft Excel to collect and analyze clinical information from the patients’ records. Data from 1994 to 1996, including preoperative clinical findings, surgical procedure, postoperative behavior, and subsequent outpatient visits, were entered into the database retrospectively and thereafter prospectively. Statistical Analysis Results were analyzed using the Student t test for comparison of means, a chi-square analysis for 2 ⫻ 2 tables, and Kaplan-Meier survival curves for long-term
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Figure 7. (Shaarawy) Intraocular pressure before and after DSCI (D ⫽ days; W ⫽ weeks; M ⫽ months).
success rate analysis. The Wilcoxon test was used for between-group comparisons.
Results The mean follow-up was 43.2 months ⫾ 14.3 (SD) (range 18 to 66 months). Sixty patients completed 60 months, and 6 were lost to follow-up after a minimum of 18 months. The mean IOP was 26.8 mm Hg preoperatively and 5.1 mm Hg 1 day postoperatively. The mean IOP at 3 months was 12.2 ⫾ 3.4 mm Hg, a reduction from preoperatively of 55.5%, and at 48 months, 12.24 ⫾ 4.6 mm Hg, a reduction of 55.4%. Thus, IOP was stable postoperatively (Figure 7). All patients had a shallow, diffuse subconjunctival bleb. At 60 months, the complete success rate (IOP ⬍ 21 mm Hg without medication) was 61.9% (Figure 8) and the qualified success rate (IOP ⬍ 21 mm Hg with or without medication), 94.8%. The IOP was lower than 21 mm Hg with medication in 32.3% of patients. The mean number of medications per patient, which was 2.30 ⫾ 0.76 preoperatively, was 0.49 ⫾ 0.72 after DSCI. Of patients having an IOP less than 21 mm Hg without treatment, 6 (9.2%) had an IOP between 19 and 21 mm Hg, 11 (16.9%) between 16 and 18 mm Hg, and 48 (73.8%; 45.7% of entire series) of 15 mm Hg or less. Of patients with an IOP less than 21 mm Hg with treatment, 6 (17.6%) had an IOP 1774
Figure 8. (Shaarawy) Long-term cumulative complete success of DSCI (Kaplan-Meier life-table analysis).
between 19 and 21 mm Hg, 7 (20.5%) between 16 and 18 mm Hg, and 21 (61.7%) of 15 mm Hg or less. Of the 105 eyes having DSCI, IOP was uncontrolled (mean 26.6 mm Hg) in 6 cases (5.7%), which required a reoperation (trabeculectomy or another DSCI with intraoperative mitomycin-C). The mean BCVA, which was 0.73 preoperatively, was 0.53 1 day postoperatively. Visual acuity returned to preoperative levels 1 week after surgery and remained stable over the next 5.5 years; the mean was 0.72 at 48 months and 0.73 at 66 months (Figure 9). The mean defect was 12.72 preoperatively, 11.09 at 12 months, and 8.16 at 60 months. The mean corrected lost vari-
Figure 9. (Shaarawy) Mean BCVA before and after DSCI (D ⫽ days; W ⫽ weeks; M ⫽ months).
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ance was 47.2 preoperatively, 52.19 at 12 months, and 43.98 at 60 months. According to the Brusini glaucoma staging system,16 81% of patients in the complete success group maintained stable visual fields (within the same preoperative stage) and 19% had deterioration despite an IOP of 15 mm Hg or less, pointing to pressure-independent factors. There were no significant intraoperative complications. Figure 10 shows the postoperative complications. No patient developed a shallow or flat anterior chamber, bleb-related endophthalmitis, or surgery-induced cataract. Progression of a preexisting senile cataract occurred in 23 patients (21.9%). Twenty-five patients (23.8%) required 5-FU injections. The mean number of injections was 2.9 ⫾ 1.9 and the mean time between surgery and injection, 1.8 ⫾ 2.6 months. An Nd:YAG laser goniopuncture was performed in 48 patients (45.7%). The mean time between the goniopuncture and DSCI was 13.5 ⫾ 13.0 months. The mean IOP before goniopuncture was 20.6 ⫾ 6.0 mm Hg and after goniopuncture, 10.7 ⫾ 6.3 mm Hg. The difference was statistically significant (P ⬍ .001). The immediate success rate (IOP ⬍ 18 mm Hg or IOP decrease ⬍ 5 mm Hg with initial pressure 23 mm Hg) was 91.6%. Over a mean follow-up of 45 ⫾ 16.0 months, the complete success rate in the subgroup of 48 patients requiring goniopuncture was 60.4% (29 patients) and the qualified success rate, 87.5% (42 patients).
Figure 10. (Shaarawy) Postoperative complications (A ⫽ 5-FU injections; B ⫽ cataract progression; C ⫽ bleb encapsulation; D ⫽ bleb fibrosis; E ⫽ hyphema; F ⫽ wound leak; G ⫽ choroidal detachment; H ⫽ Dellen; I ⫽ needling; K ⫽ malignant glaucoma; L ⫽ hypotony).
Discussion Classic glaucoma teachings consider surgery to be a last resort for the treatment of primary open-angle glaucoma after topical therapy and argon laser trabeculoplasty (ALT) have failed to control IOP.17 However, recent data from the Advanced Glaucoma Intervention Study18 show a race-related response to ALT, which argues for trabeculectomy before ALT in white patients. Such data are clearly at odds with the classic approach of surgery as a last-stage intervention. Most surgeons prefer to delay surgery because of the potential vision-threatening complications of standard trabeculectomy performed with or without antimetabolites. Complications include hypotony, hyphema, a flat anterior chamber, choroidal effusion or hemorrhage, surgery-induced cataract, and bleb failure.1–12 However, surgery is an effective way to lower IOP. Bylsma17 hypothesizes that if the safety margin of glaucoma surgery could be increased significantly without sacrificing efficacy, surgical intervention for glaucoma might be considered earlier. To avoid the postoperative complications of trabeculectomy (Table 2), some authors propose tightly closing the scleral flap with secondary suturelysis using an argon laser.19 More recently, Zimmerman et al.20,21 reported favorable results of nonpenetrating trabeculectomy in phakic and aphakic patients. Stegmann and coauthors22 describe a similar technique in which the scleral space is filled with viscoelastic substance. They report a complete success of rate of 82.7% and a qualified success rate of 89.0% over a 35-month follow-up. Kozlov et al.13 and Fyodorov23 describe placing a collagen implant in the scleral bed to enhance the filtration of deep sclerectomy. Sanchez and coauthors15 report a better surgical outcome when the collagen implant is used. Chiou et al.24,25 report ultrasonic biomicroscopy findings consistent with IOP lowering by aqueous filtration through the thin remaining TDM to an area under the scleral flap, which was hypothetically kept open by the presence of the collagen implant. Other available implants are the reticulated hyaluronic acid implant26 and the hydrophilic acrylic nonabsorbable implant (E. Dahan, MD, personal communication, February 2001). The DSCI technique prevents sudden hypotony after trabeculectomy by creating progressive filtration of
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Table 2. Postoperative complications of trabeculectomy in the literature compared with those in the current study. Complication (%) Study* Current 11
Molteno
Number of Eyes
Hyphema
105
8.5
Hypotony
Shallow AC
Choroid Detach
Further Surgery
0.9
0
6.6
5.7
Uveitis 0
Cataract Progress 0
Endoph 0
289
8.0
NAD
6.0
10.7
4.8
NAD
NAD
NAD
66
53.0
NAD
11.6
NAD
NAD
4.5
9.8
NAD
1
387
22.0
5.0
16.0
NAD
NAD
2.0
14.2
0
1
112
40.0
25.0
28.0
NAD
NAD
5.0
NAD
0
Akafo
81
NAD
NAD
NAD
NAD
6.1
NAD
NAD
1.2
D’Ermo12
90
8.7
NAD
NAD
4.4
NAD
NAD
2.2
NAD
444
6.9
NAD
13.1
5.3
6.2
0.8
NAD
0.5
Zaidi8 Watson Watson 9
Mills10
AC ⫽ anterior chamber; Choroid Detach ⫽ choroidal detachment; Progress ⫽ progression; Endoph ⫽ endophthalmitis; NAD ⫽ no available data *First author listed only
aqueous humor from the anterior chamber to the subconjunctival space without perforating the eye. In an experimental model, Vaudaux and coauthors27 studied the aqueous dynamics through the remaining thin TDM membrane and found that the outflow resistance was low but sufficient to prevent the immediate postoperative complications of trabeculectomy. The short-term success of DSCI has been reported to be favorable. Demailly et al.28,29 report a mean decrease in IOP of 9.1 ⫾ 7.1 mm Hg after 219 DSCI procedures. The success rate without glaucoma medication was 89% at 6 months and 75.6% at 16 months. With medication, it was 97% and 79%, respectively. Kozlov et al.30 report an 85% success rate but gave no information on success criteria or follow-up. Karlen et al.31 report a complete success rate of 44.6% and a qualified success rate of 97.7% at 36 months. In our study, except for the first week after surgery, visual acuity was unaffected by DSCI. This may be because the eye was not perforated, preventing inflammation, mydriatics use, and sudden hypotony. Furthermore, visual acuity remained stable because no surgeryrelated cataracts developed. The major intraoperative complication was perforation of the thin TDM during the deep sclerectomy dissection. This was common in the learning phase of deep sclerectomy, occurring in 3 of the first 10 surgeries (30.0%). The complication rate sharply decreased as surgical experience increased; only 3 of the subsequent 101 deep sclerectomies (2.9%) resulted in perforation. The postoperative complications and final outcome 1776
in the 6 patients with intraoperative perforation of the TDM15 were similar to those in patients who had standard trabeculectomy. The early postoperative complications included the presence of subtle hyphema (unleveled) in 8.5% of cases. The small amount of blood in the anterior chamber was likely blood reflux from the scleral bed through the anterior trabeculum or through undetected microperforations. Twenty-three percent of patients required subconjunctival 5-FU injections for fibrotic or encysted blebs. The mean number of injections per patient (2.9 ⫾ 1.9) was significantly lower than in previous studies using 5-FU after trabeculectomy (7 to 21 injections).32 Most injections were administered during the first 2 months postoperatively. One patient developed malignant glaucoma on the first postoperative day. It was successfully treated with scopolamine. Forty-six percent of patients required an Nd:YAG goniopuncture. Goniopunctures were performed shortly after DSCI when there was insufficient percolation of aqueous humor at the TDM, probably due to the lack of surgical dissection. Goniopunctures performed more than 9 months after surgery were for low filtration, which was probably the result of fibrosis of the TDM because the goniopuncture increased aqueous humor filtration and decreased IOP. The success rate of Nd:YAG laser goniopuncture was satisfactory, with an immediate reduction in mean IOP of 48.1%. By opening the TDM, however, goniopuncture transformed a nonper-
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forating filtration procedure into a perforating one. Although the potential risk of late bleb-related endophthalmitis may increase after goniopuncture, no cases occurred during the study. Others report Nd:YAG goniopuncture success rates between 68% and 94%.29,30,33 These results compare favorably with our success rate of 91.6%. In a prospective comparative study of DSCI and standard trabeculectomy in patients with open-angle glaucoma,34 69% in the DSCI group and 57% in the trabeculectomy group had an IOP lower than 21.0 mm Hg without medication at 24 months. The complication rate was significantly lower in the DSCI group. The authors conclude that the success rate of DSCI might be comparable to that of trabeculectomy, with fewer complications. Chiou and coauthors35 report statistically significantly lower flare measurements after DSCI than after trabeculectomy. This may be the result of the lack of iridectomy, irrigation, and anterior chamber penetration with DSCI. In conclusion, DSCI appears to be a promising new nonperforating filtration procedure. In our study, the success rate after 5.5 years of follow-up was satisfactory for all types of primary and secondary open-angle glaucoma studied. The immediate postoperative complication rate was low, and visual acuity was not significantly affected.
References 1. Watson PG, Jakeman C, Ozturk M, et al. The complications of trabeculectomy (a 20-year follow-up). Eye 1990; 4:425– 438 2. Kao SF, Lichter PR, Musch DC. Anterior chamber depth following filtration surgery. Ophthalmic Surg 1989; 20: 332–336 3. Stewart WC, Shields MB. Management of anterior chamber depth after trabeculectomy. Am J Ophthalmol 1988; 106:41– 44 4. Brubaker RF, Pederson JE. Ciliochoroidal detachment. Surv Ophthalmol 1983; 27:281–289 5. Gressel MG, Parrish RK II, Heuer DK. Delayed nonexpulsive suprachoroidal hemorrhage. Arch Ophthalmol 1984; 102:1757–1760 6. Ruderman JM, Harbin TS Jr, Campbell DG. Postoperative suprachoroidal hemorrhage following filtration procedures. Arch Ophthalmol 1986; 104:201–205 7. Freedman J, Gupta M, Bunke A. Endophthalmitis after trabeculectomy. Arch Ophthalmol 1978; 96:1017–1018
8. Zaidi AA. Trabeculectomy: a review and 4-year followup. Br J Ophthalmol 1980; 64:436 – 439 9. Akafo SK, Goulstine DB, Rosenthal AR. Long-term post trabeculectomy intraocular pressures. Acta Ophthalmol 1992; 70:312–316 10. Mills KB. Trabeculectomy: a retrospective long-term follow-up of 444 cases. Br J Ophthalmol 1981; 65:790 –795 11. Molteno ACB, Bosma NJ, Kittelson JM. Otago glaucoma surgery outcome study: long-term results of trabeculectomy—1976 to 1995. Ophthalmology 1999; 106:1742–1750 12. D’Ermo F, Bonomi L, Doro D. A critical analysis of the long-term results of trabeculectomy. Am J Ophthalmol 1979; 88:829 – 835 13. Kozlov VI, Bagrov SN, Anisimova SY, et al. [Deep sclerectomy with collagen]. [Russian] Eye Microsurgery 1990; 3:44 – 46 14. Hamel M, Shaaraway T, Mermoud A. Deep sclerectomy with collagen implant in patients with glaucoma and high myopia. J Cataract Refract Surg 2001; 27:1410 –1417 15. Sanchez E, Schnyder CC, Mermoud A. Re´sultats comparatifs de la scle´rectomie profonde transforme´e en trabe´culectomie et de la trabe´culectomie classique. Klin Monatsbl Augenheilkd 1997; 210:261–264 16. Brusini P. Clinical use of a new method for visual field damage classification in glaucoma. Eur J Ophthalmol 1996; 6:402– 407 17. Bylsma S. Nonpenetrating deep sclerectomy: collagen implant and viscocanalostomy procedures. Int Ophthalmol Clin 1999; 39(3):103–119 18. The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS). 4. Comparison of treatment outcomes within race; seven-year results. Ophthalmology 1998; 105:1146 –1164 19. Savage JA, Condon GP, Lytle RA, Simmons RJ. Laser suture lysis after trabeculectomy. Ophthalmology 1988; 95:1631–1637; discussion by AE Kolker, 1637 20. Zimmerman TJ, Kooner KS, Ford VJ, et al. Trabeculectomy vs. nonpenetrating trabeculectomy: a retrospective study of two procedures in phakic patients with glaucoma. Ophthalmic Surg 1984; 15:734 –740 21. Zimmerman TJ, Kooner KS, Ford VJ, et al. Effectiveness of nonpenetrating trabeculectomy in aphakic patients with glaucoma. Ophthalmic Surg 1984; 15:44 –50 22. Stegmann R, Pienaar A, Miller D. Viscocanalostomy for open-angle glaucoma in black African patients. J Cataract Refract Surg 1999; 25:316 –322 23. Fyodorov, SN. [Non penetrating deep sclerectomy in open-angle glaucoma]. [Russian] Eye Microsurgery 1989; 2:52–55 24. Chiou AG-Y, Mermoud A, Underdahl JP, Schnyder CC. An ultrasound biomicroscopic study of eyes after deep sclerectomy with collagen implant. Ophthalmology 1998; 105:746 –750
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25. Chiou AG-Y, Mermoud A, He´diguer S-EA, et al. Ultrasound biomicroscopy of eyes undergoing deep sclerectomy with collagen implant. Br J Ophthalmol 1996; 80: 541–544 26. Sourdille P, Santiago P-Y, Villain F, et al. Reticulated hyaluronic acid implant in nonperforating trabecular surgery. J Cataract Refract Surg 1999; 25:332–339 27. Vaudaux J, Uffer S, Mermoud A. Aqueous dynamics after deep sclerectomy: in vitro study. Ophthalmic Pract 1998; 16:204 –209 28. Demailly P, Lavat P, Kretz G, Jeanteur-Lunel MN. Nonpenetrating deep sclerectomy (NPDS) with or without collagen device (CD) in primary open-angle glaucoma: middle-term retrospective study. Int Ophthalmol 1996/ 97; 20:131–140 29. Demailly P, Jeanteur-Lunel MN, Berkani M, et al. La scle´rectomie profonde non perforante associe´e a` la pose d’un implant de collage´ne dans le glaucome. J Fr Ophtalmol 1996; 19:659 – 666 30. Kozlov VI, Bagrov SN, Anisimova SY, et al. [Nonpenetrating deep sclerectomy with collagen]. [Russian] Eye Microsurgery 1990; 3:157–162 31. Karlen ME, Sanchez E, Schnyder CC, et al. Deep sclerectomy with collagen implant: medium term results. Br J Ophthalmol 1999; 83:6 –11
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32. The Fluorouracil Filtering Surgery Study Group. Fluorouracil filtering surgery study one-year follow-up. Am J Ophthalmol 1989; 108:625–35 33. Mermoud A, Karlen M-E, Schnyder CC, et al. Nd:YAG goniopuncture after deep sclerectomy with collagen implant. Ophthalmic Surg Lasers 1999; 30:120 –5 34. Mermoud A, Schnyder CC, Sickenberg M, et al. Comparison of deep sclerectomy with collagen implant and trabeculectomy in open-angle glaucoma. J Cataract Refract Surg 1999; 25:323–331 35. Chiou AG-Y, Mermoud A, Jewelewicz DA. Post-operative inflammation following deep sclerectomy with collagen implant versus standard trabeculectomy. Graefes Arch Clin Exp Ophthalmol 1998; 236:593– 596
From Hoˆpital Ophtalmique Jules Gonin, Department of Ophthalmology, University of Lausanne, Lausanne, Switzerland (Shaarawy, Karlen, Schnyder, Achache, Sanchez, Andre´ Mermoud), and the Glaucoma Unit, Memorial Research Institute of Ophthalmology, Giza, Egypt (Shaarawy). Presented at the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, May 2000.
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