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Combined cataract extraction and Baerveldt glaucoma drainage implant
Combined Cataract Extraction and Baerveldt Glaucoma Drainage Implant Indications and Outcomes Kara B. Hoffman, MD,1 Robert M. Feldman, MD,2 Donald L. Budenz, MD,1 Steven J. Gedde, MD,1 Grace Abou Chacra, MD,2 Joyce C. Schiffman, MS1 Purpose: To report the indications and outcomes of simultaneous cataract extraction (CE) and Baerveldt glaucoma drainage implant surgery. Design: Noncomparative, interventional, retrospective, consecutive case series. Participants: Thirty-three eyes of 33 patients. Intervention: Combined phacoemulsification CE and Baerveldt glaucoma drainage implant (BGI) surgery at two tertiary care referral centers. Main Outcome Measures: Visual acuity, intraocular pressure (IOP), and complications. Results: The study included 33 eyes of 33 patients followed for an average of 15.4 months (range, 3.0 – 46.9). The most common indication for combined CE and Baerveldt glaucoma drainage implant surgery was a history of prior failed trabeculectomy. Postoperative visual acuity at last follow-up was ⱖ20/40 in 12 of 33 patients (36%). IOP was reduced from a mean (⫾ standard deviation) of 21 ⫾ 7.3 mmHg preoperatively to 13.1 ⫾ 3.5 mmHg at last follow-up visit (P ⬍ 0.001). The number of antiglaucoma medications was reduced from a mean (⫾ standard deviation) of 2.3 ⫾ 1.0 preoperatively to 0.7 ⫾ 1.1 at last follow-up (P ⬍ 0.001). Three eyes met our criteria for failure, and cumulative survival of the glaucoma surgery at 18 months was 89%. Intraoperative complications were all related to the cataract surgery, whereas early and late postoperative complications were related both to the CE and BGI surgery. Conclusions: Combined CE and Baerveldt glaucoma drainage implant placement seems to be a safe and effective surgical option and may be preferred in certain clinical situations. Ophthalmology 2002;109:1916 –1920 © 2002 by the American Academy of Ophthalmology. Cataracts and glaucoma frequently coexist in the elderly population. When medical management of glaucoma fails and surgery becomes necessary, many surgeons will elect to combine cataract extraction (CE) with the glaucoma surgery. A trabeculectomy is usually selected as the glaucoma procedure to be performed in conjunction with the cataract surgery. However, conjunctival scarring from prior surgery may reduce the likelihood of a successful trabeculectomy, even with the adjunctive use of an antimetabolite.1 Furthermore, trabeculectomy has a lower success rate when performed for secondary glaucomas and also seems to be a less desirable surgical option in patients who have previously had a complication from trabeculectomy, such as a lateonset bleb leak or bleb-associated infection. Originally received: November 5, 2001. Accepted: March 22, 2002. Manuscript no. 210924. 1 Bascom Palmer Eye Institute, Department of Ophthalmology, University of Miami School of Medicine, Miami, Florida. 2 University of Texas Health Science Center - Houston and Hermann Eye Center, Houston, Texas. The authors have no proprietary interest in any of the materials used in this study. Correspondence to Donald L. Budenz, MD, Bascom Palmer Eye Institute, 900 NW 17th St, Miami, FL 33136.
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© 2002 by the American Academy of Ophthalmology Published by Elsevier Science Inc.
Glaucoma drainage devices offer an alternative surgical approach to provide intraocular pressure (IOP) reduction.2–10 Our purpose is to report the indications and outcomes of simultaneous CE and Baerveldt Glaucoma Implant (BGI, Pharmacia and Upjohn, Kalamazoo, MI) surgery.
Patients and Methods Approval for the study was obtained from the Human Subjects Committees of the University of Miami and the University of Texas-Houston Schools of Medicine. A computerized search for patients undergoing simultaneous CE and glaucoma drainage implant surgery at either institution between May 1, 1996, and March 31, 2001, was performed using surgical current procedural terminology codes. Only patients who underwent CE using phacoemulsification combined with BGI surgery were included in this study. Patients were then excluded if the cataract was removed by means of a large-incision extracapsular technique, if additional procedures were performed at the same time as the combined surgery (such as penetrating keratoplasty, pars plana vitrectomy [PPV], or trabeculectomy), or if a glaucoma drainage implant other than a BGI was placed. Second eyes of the same patient and eyes with less than 3 months of follow-up were also excluded. Demographic characteristics of the study population were determined, including age, gender, and race. The indications for ISSN 0161-6420/02/$–see front matter PII S0161-6420(02)01185-5
Hoffman et al 䡠 Combined Cataract Extraction and Baerveldt Drainage Implant combined CE/BGI, intraocular lens (IOL) type, and operative and postoperative complications were recorded. Visual acuity, IOP, and number of antiglaucoma medications were determined preoperatively and postoperatively at months 3, 6, 12, and 18, and at last follow-up. Failure was defined as a sustained IOP of ⬎21 mmHg or ⬍5 mmHg for two or more visits or reoperation for glaucoma. All surgical procedures were performed by one of five glaucoma specialists at two tertiary care institutions. A similar operative technique was used in all patients. A fornix-based flap of conjunctiva and Tenon’s capsule was raised in the superotemporal quadrant. The lateral and superior rectus muscles were sequentially isolated using muscle hooks, and a wing of the BGI (BG101-350) was placed under each muscle belly. The implant was then secured to the sclera using two interrupted sutures. The tube was ligated in a watertight fashion near the tube–plate junction using a 7-0 polyglactin suture. One to three fenestrations were made in the tube proximal to the ligation suture in some patients using a TG 160 needle (Ethicon, Somerville, NJ). The cataract was then removed by means of a standard clear corneal phacoemulsification technique. Once this was completed, the corneal incision was closed with one or two interrupted 10-0 nylon sutures. The implant tube was trimmed to an appropriate length and inserted into the anterior chamber through a 23-gauge needle track. A piece of donor cornea, sclera, or dura mater was used to cover the limbal portion of the tube. The conjunctiva and Tenon’s capsule were reapproximated to the limbus. Subconjunctival injections of dexamethasone (Decadron) and antibiotic were given. Topical antibiotics were prescribed four times per day for 1 week, and topical steroids were used four to eight times per day for 6 to 8 weeks and tapered at the surgeon’s discretion. Results are presented as mean ⫾ standard deviation with median and range where indicated. Preoperative and postoperative mean IOP and mean number of glaucoma medications were compared using paired sample Student’s t tests. Kaplan-Meier survival analysis was also performed. Before reviewing the data, success was defined as IOP ⱖ 5 or ⱕ 21 mmHg with or without glaucoma medications and no need for additional glaucoma surgery. Patients with transient IOP elevation that responded to medical therapy were considered successes.
Results Combined phacoemulsification, IOL implantation, and Baerveldt glaucoma drainage implant surgery was performed in 77 eyes at the two institutions. Of these, three eyes were excluded, because surgery was being performed on the second eye of the same patient. Five eyes were excluded secondary to placement of a drainage device other than a BGI. Twenty-eight eyes were excluded because an additional procedure (e.g., penetrating keratoplasty or PPV) was performed at the same time as the combined CE/BGI. Eight eyes were excluded for insufficient length of follow-up. Thus, a total of 33 eyes of 33 patients were identified as meeting inclusion/exclusion criteria. Demographic data are shown in Table 1. The average age at time of surgery was 65.6 years, with a range of 28 to 84 years. Gender and race distribution were roughly equal. Race information on one patient was unknown. Nineteen right eyes were included. The most commonly used IOL was the Alcon acrylic MA60BM (Fort Worth, TX) (18 of 33, 55%). A Staar silicone foldable posterior chamber IOL (Monrovia, CA) was implanted in 7 of 33 eyes (21%), whereas an Alcon polymethyl methacrylate posterior chamber IOL was used in 6 of 33 eyes (18%). In one eye each, an Alcon acrylic posterior chamber MA30BA and Alcon polymethyl methacrylate anterior chamber MTA3UO was placed.
Table 1. Demographic Characteristics Characteristic Age (yrs, mean ⫾ standard deviation) Gender Male Female Race Nonhispanic white Black Hispanic Eye Right Left
65.6 ⫾ 13.9 16 (48%) 17 (52%) 10 (30%) 10 (30%) 12 (36%) 19 (58%) 14 (42%)
Indications for placing a BGI at the time of cataract surgery are listed in Table 2. The most common indication was a history of failed trabeculectomy in 19 of 33 eyes (58%). In addition, 3 of 33 eyes (9%) had a diagnosis of iridocorneal endothelialization syndrome, and 3 of 33 (9%) had complications from a previous trabeculectomy, including a chronic bleb leak in one patient and blebitis in two patients. Although the bleb leak persisted until the combined CE/BGI surgery was performed, the two cases of blebitis resolved with treatment before surgery. Patients were followed for an average of 15.4 months (standard deviation, 9.4), with a median of 13.1 months and a range of 3.0 to 46.9 months. A summary of visual acuity outcomes is shown in Table 3. Improvement in visual acuity from the preoperative level occurred in 20 of 33 eyes (61%). The visual acuity of five patients was unchanged postoperatively. Two patients had poor visual acuity preoperatively (hand motions, 20/400) secondary to scleral perforation and aniridic glaucoma, respectively. Another patient developed postoperative cystoid macular edema that limited her visual acuity to 20/60 at 6 Table 2. Indication for Combined Baerveldt Glaucoma Drainage Implant/Cataract Extraction Number of Eyes (%)*
Indication Failed trabeculectomy Iridocorneoendothelial syndrome Chronic angle-closure glaucoma Blebitis Chronic bleb leak Posterior blepharitis Neovascular glaucoma Aniridia Scleral perforation after radiation therapy Failed viscocanalostomy Increased IOP with corneal graft rejection
19 (58) 3 (9) 2 (6) 2 (6) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3)
* n ⫽ 33. IOP ⫽ intraocular pressure.
Table 3. Visual Acuity Outcomes Visual Acuity
Preoperative (%)
Last Follow-up (%)
20/20–20/40 20/50–20/100 ⬍20/100
0/33 (0) 10/33 (30.3) 23/33 (69.7)
12/33 (36.4) 8/33 (24.2) 13/33 (39.4)
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Ophthalmology Volume 109, Number 10, October 2002 Table 4. Intraocular Pressure at Specified Times Visit
Mean Intraocular Pressure
Standard Deviation
Preoperative 3 mos 6 mos 12 mos 18 mos Last follow-up
21.7 11.8 11.9 11.8 13.1 13.1
7.3 5.1 4.8 4.4 3.2 3.5
Table 5. Number of Medications Necessary to Control Intraocular Pressure P Value* ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
Visit
Mean No. of Medications
Standard Deviation
P Value*
Preoperative 3 mos 6 mos 12 mos 18 mos Last follow-up
2.3 0.5 0.7 1.0 0.4 0.7
1.0 0.9 1.0 1.4 0.7 1.1
⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
* Paired Student’s t-test. * Paired Student’s t-test
months. The visual acuity of another patient remained 20/400 postoperatively because of hypotony-induced choroidal effusions. This patient was considered a failure, because drainage of the choroidal effusions with Baerveldt exchange was necessary 1 year after the initial surgery. The visual acuity after the second procedure, however, improved to 20/100. The visual acuity of the remaining patient failed to improve secondary to glaucoma involving fixation. Intraoperative or postoperative lens dislocation occurred in three of the eyes that had visual loss. One patient’s visual acuity decreased from 20/200 to hand motions 6 weeks after surgery complicated by a capsular rupture without vitreous loss. This patient developed aqueous misdirection and underwent PPV with IOL repositioning. The visual acuity remained hand motions at last follow-up (8 months postoperative). Intraoperative dislocation of the lens developed in another patient because of a zonular dehiscence leading to an anterior vitrectomy with placement of an anterior chamber IOL. This patient underwent PPV with removal of retained lens fragments 1 week postoperatively, and the visual acuity decreased from hand motions preoperatively to light perception, where it remained until the last follow-up at 18 months. Another patient’s visual acuity dropped from 20/400 to hand motions after intraoperative lens dislocation. A subsequent PPV was performed to remove the retained lens fragments, and a posterior chamber IOL was placed in the sulcus. The postoperative decline in visual acuity was secondary to glaucomatous progression, leading to loss of fixation. Two eyes had very poor vision preoperatively, in part secondary to the lens opacity and in part because of other factors. The visual acuity of one patient with choroidal effusions decreased from finger counting preoperatively to hand motions at 6 months, where it remained even after drainage of the choroidal effusions. Another patient with neovascular glaucoma secondary to a hemiretinal vein occlusion had a cataract, precluding administration of panretinal photocoagulation. This patient lost 1 line of vision at the 1-year follow-up compared with preoperatively. Three patients experienced decreased visual acuity to the level of finger counting postoperatively because of corneal edema. In all three patients, the onset of the corneal edema was delayed, occurring 6, 12, and 13 months postoperatively. In all cases, the corneal edema was diffuse. Two of these patients underwent penetrating keratoplasty with (n ⫽ 1) or without (n ⫽ 1) revision of the tube, and one of these recovered vision to 20/200 (the same acuity as before CE/BGI). Tables 4 and 5 show mean IOPs and number of glaucoma medications used preoperatively and postoperatively at months 3, 6, 12, and 18, and at last follow-up. A statistically significant difference was found in both the reduction in IOP and in the number of medications used at all points during follow-up. Three patients met our criteria for failure. The first, mentioned earlier, had intraoperative complications related to the cataract
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surgery and later developed aqueous misdirection with an IOP of 42. He underwent a PPV/IOL repositioning at 6 weeks postoperative for the same. A second patient failed at 6 months because of sustained elevated IOP. The third patient has also been mentioned previously. She failed at 1 year secondary to hypotony and choroidal effusions and underwent a glaucoma reoperation at that time. The Kaplan-Meier survival curve is shown in Figure 1. Of the 33 eyes that underwent combined CE and BGI surgery, our cumulative survival of the Baerveldt glaucoma implant was 94% at 6 months, 94% at 12 months, and 89% at 18 months. Table 6 lists the operative, early postoperative, and late postoperative complications, excluding eyes considered failures, the courses of which were mentioned previously. Operative complications all occurred during the cataract portion of the surgery. Of the two instances of postoperative choroidal effusions, one occurred in an eye that had intraoperative zonular dehiscence with retained lens fragments. A PPV with removal of retained lens fragments and drainage of choroidal effusions was performed 1 week later. In the other patient, the choroidals were drained at 5 months postoperative. One eye experienced retraction of the BGI tube that was repositioned at 2 months. This same eye developed corneal edema and had a second tube repositioning combined with a penetrating keratoplasty at 15 months after the initial surgery. Two other eyes developed corneal edema at 12 and 13 months postoperatively.
Figure 1. Cumulative proportion successful (intraocular pressure ⱖ 5 and ⱕ 21 mmHg with or without glaucoma medications and no need for glaucoma reoperation) after combined cataract extraction and Baerveldt implant. Hash marks represent time of last follow-up visit.
Hoffman et al 䡠 Combined Cataract Extraction and Baerveldt Drainage Implant Table 6. Operative and Postoperative Complications Complication Capsular rent (patient developed aqueous misdirection 6 wks postoperative) Zonular dehiscence with lens fragments in vitreous Lens dislocation Vitreous prolapse alone Choroidal effusion with IOP ⱖ5 Retraction of BGI tube Recurrent iritis Cystoid macular edema Corneal edema Fibrin plugging BGI tube ostium Macular striae in absence of hypotony
Timing of Occurrence
Number of Eyes
Intraoperative
1
Intraoperative
1
Intraoperative Intraoperative 1 wk, 3 mos postoperative 2 mos postoperative 1–3 mos postoperative 6 mos postoperative 6 mos, 12 mos, 13 mos postoperative 12 mos postoperative 18 mos postoperative
1 1 2 1 1 1 3 1 1
BGI ⫽ Baerveldt glaucoma drainage implant; IOP ⫽ intraocular pressure.
One of these underwent a penetrating keratoplasty at 20 months. In another eye, fibrin was noted to be blocking the tube ostium without causing elevation of IOP. This fibrin was needled at 12 months without complication or recurrence.
Discussion Combined CE and trabeculectomy has become increasingly common in treating glaucoma patients afflicted with lens opacities. The long-term success of this procedure in terms of IOP control and improvement in visual acuity has been well documented.11–13 Addressing IOP control, Yu’s group11 found no statistically significant difference after a mean of 21 months follow-up between eyes that had undergone combined extracapsular CE with IOL implantation and trabeculectomy versus eyes that had undergone trabeculectomy alone. This success rate may even be improved in patients who undergo small-incision cataract surgery along with trabeculectomy or with the adjunctive use of antimetabolites.12,14,15 Situations exist, however, in which performing a trabeculectomy at the same time as cataract surgery may not be desirable, such as a history of failed trabeculectomy, secondary glaucoma, or previous bleb-associated complication. Whereas bleb-related infections are severe and visually devastating complications of trabeculectomy, infection related to a glaucoma drainage device seems to be a rare occurrence16 and seems to occur only after exposure of the device.17 The patients in our cohort tended to have more complicated or refractory types of glaucoma, many of them having failed at least one prior glaucoma procedure. Even so, our study reveals a statistically significant decrease in IOP and number of glaucoma medications used at all points during follow-up. Our cumulative success of the BGI at 18 months was 89%, comparable to that of combined phacotrabeculectomy.12,18
Budenz et al12 have reported a 1-year cumulative success of phacotrabeculectomy with mitomycin-C to be 90% and with 5-fluorouracil to be slightly greater than 72% using success criteria identical to that in this study. Mamalis et al18 reported that 81% of patients had an IOP ⱕ 19 mmHg after 18 months of follow-up. Although IOP control in this study was similar to that found with phacotrabeculectomy, the visual acuity results were worse. Sixty-one percent of our patients experienced at least 1 line of improvement in Snellen acuity compared with preoperatively, with only 36% having a visual acuity of 20/40 or better. Carlson et al19 reported a postoperative visual acuity of ⱖ 20/40 in 27 of 29 eyes that underwent combined phacotrabeculectomy either with or without mitomycin-C, and Cohen et al20 found a postoperative visual acuity of ⱖ 20/40 in at least 85% of eyes. The poorer visual acuity results in this study are in large part secondary to preexisting ocular conditions that limited visual recovery independent of the cataract. In this study, 3 of 33 eyes (9%) developed corneal edema. The etiology in at least one case was most likely endothelial cell injury during phacoemulsification, an entity that has been well described.21,22 Another possibility is that the BGI tube caused direct endothelial damage.16,23 Even though our incidence of corneal edema is not negligible, it is much lower than that found by Bhattacharyya’s group.24 They reported the outcomes of eyes with functioning glaucoma drainage implants that subsequently underwent CE with IOL placement. In these eyes, there was no significant increase in IOP or number of medications necessary to control the glaucoma after the CE, but 3 of 11 eyes (27%) developed postoperative corneal edema, one of which experienced loss of IOP control. Although the etiology of the corneal edema in their study could have been related to endothelial cell injury during phacoemulsification or secondary to the drainage tube itself, it is certainly conceivable that repeated endothelial cell injury from multiple surgical procedures could have caused the corneal decompensation. In such eyes, it might be preferable to perform the CE and BGI at the same time. To our knowledge, this study is the first report of the surgical outcomes of combined CE/BGI. Although it suffers from its retrospective design and lack of randomization to different treatment groups, it describes a new option in combined surgery for a select group of difficult patients, in most of whom phacotrabeculectomy would be at high risk for failure. Understanding the limitations of this study, it seems that combined CE/BGI is a safe and effective approach in treating patients with cataract and glaucoma and may be an option in combined cases at high risk for failure of trabeculectomy.
References 1. Rockwood EJ, Parrish RK III, Heuer DK, et al. Glaucoma filtering surgery with 5-fluorouracil. Ophthalmology 1987;94: 1071– 8. 2. Krishna R, Godfrey DG, Budenz DL, et al. Intermediate-term
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4.
5. 6. 7. 8. 9. 10. 11.
12. 13.
14. Joos KM, Bueche MJ, Palmberg PF, et al. One-year follow-up results of combined mitomycin C trabeculectomy and extracapsular cataract extraction. Ophthalmology 1995; 102:76 – 83. 15. Lederer CM Jr. Combined cataract extraction with intraocular lens implant and mitomycin-augmented trabeculectomy. Ophthalmology 1996;103:1025–34. 16. Nguyen QH, Budenz DL, Parrish RK II. Complications of Baerveldt glaucoma drainage implants. Arch Ophthalmol 1998;116:571–5. 17. Gedde SJ, Scott IU, Tabandeh H, et al. Late endophthalmitis associated with glaucoma drainage implants. Ophthalmology 2001;108:1323–7. 18. Mamalis N, Lohner S, Rand AN, Crandall AS. Combined phacoemulsification, intraocular lens implantation, and trabeculectomy. J Cataract. Refract Surg 1996;22:467–73. 19. Carlson DW, Alward WLM, Barad JP, et al. A randomized study of mitomycin augmentation in combined phacoemulsification and trabeculectomy. Ophthalmology 1997;104:719 – 24. 20. Cohen JS, Greff LJ, Novack GD, Wind BE. A placebocontrolled, double-masked evaluation of mitomycin C in combined glaucoma and cataract procedures. Ophthalmology 1996;103:1934 – 42. 21. Kohlhaas M, Klemm M, Kammann J, Richard G. Endothelial cell loss secondary to two different phacoemulsification techniques. Ophthalmic Surg Lasers 1998;29:890 –5. 22. Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification. J Cataract Refract Surg 1996;22:1079 – 84. 23. Zalloum JN, Ahuja RM, Shin D, Weiss JS. Assessment of corneal decompensation in eyes having undergone Molteno shunt procedures compared to eyes having undergone trabeculectomy. CLAO J 1999;25:57– 60. 24. Bhattacharyya CA, WuDunn D, Lakhani V, et al. Cataract surgery after tube shunts. J Glaucoma 2000;9:453–7.
1. 2. 3. 4. 5. 6.
3.
outcomes of 350-mm2 Baerveldt glaucoma implants. Ophthalmology 2001;108:621– 6. Huang MC, Netland PA, Coleman AL, et al. Intermediateterm clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol 1999;127:27–33. Lloyd MA, Baerveldt G, Fellenbaum PS, et al. Intermediateterm results of a randomized clinical trial of the 350- versus 500-mm2 Baerveldt implant. Ophthalmology 1994;101:1456 – 63; discussion 1463– 4. Mills RP, Reynolds A, Emond MJ, et al. Long-term survival of Molteno glaucoma drainage devices. Ophthalmology 1996; 103:299 –305. Perkins TW, Gangnon R, Ladd W, et al. Molteno implant with mitomycin C: intermediate-term results. J Glaucoma 1998;7: 86 –92. Price FW Jr, Wellemeyer M. Long-term results of Molteno implants. Ophthalmic Surg 1995;26:130 –5. Siegner SW, Netland PA, Urban RC Jr, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology 1995;102:1298 –307. Smith MF, Doyle JW, Sherwood MB. Comparison of the Baerveldt glaucoma implant with the double-plate Molteno drainage implant. Arch Ophthalmol. 1995;113. 444 –7. Topouzis F, Coleman AL, Choplin N, et al. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol 1999;128:198 –204. Yu CBO, Chong NHV, Caesar RH, et al. Long-term results of combined cataract and glaucoma surgery versus trabeculectomy alone in low-risk patients. J Cataract Refract Surg 1996; 22:352–7. Budenz DL, Pyfer M, Singh K, et al. Comparison of phacotrabeculectomy with 5-fluorouracil, mitomycin-C, and without antifibrotic agents. Ophthalmic Surg Lasers 1999;30:367–74. Yamagami S, Hamada N, Araie M, Shirato S. Risk factors for unsatisfactory intraocular pressure control in combined trabeculectomy and cataract surgery. Ophthalmic Surg Lasers 1997;28:476 – 82.
D C D E B B
Answers:
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© 2002 by the American Academy of Ophthalmology Published by Elsevier Science Inc.
Glaucoma drainage devices offer an alternative surgical approach to provide intraocular pressure (IOP) reduction.2–10 Our purpose is to report the indications and outcomes of simultaneous CE and Baerveldt Glaucoma Implant (BGI, Pharmacia and Upjohn, Kalamazoo, MI) surgery.
Patients and Methods Approval for the study was obtained from the Human Subjects Committees of the University of Miami and the University of Texas-Houston Schools of Medicine. A computerized search for patients undergoing simultaneous CE and glaucoma drainage implant surgery at either institution between May 1, 1996, and March 31, 2001, was performed using surgical current procedural terminology codes. Only patients who underwent CE using phacoemulsification combined with BGI surgery were included in this study. Patients were then excluded if the cataract was removed by means of a large-incision extracapsular technique, if additional procedures were performed at the same time as the combined surgery (such as penetrating keratoplasty, pars plana vitrectomy [PPV], or trabeculectomy), or if a glaucoma drainage implant other than a BGI was placed. Second eyes of the same patient and eyes with less than 3 months of follow-up were also excluded. Demographic characteristics of the study population were determined, including age, gender, and race. The indications for ISSN 0161-6420/02/$–see front matter PII S0161-6420(02)01185-5
Hoffman et al 䡠 Combined Cataract Extraction and Baerveldt Drainage Implant combined CE/BGI, intraocular lens (IOL) type, and operative and postoperative complications were recorded. Visual acuity, IOP, and number of antiglaucoma medications were determined preoperatively and postoperatively at months 3, 6, 12, and 18, and at last follow-up. Failure was defined as a sustained IOP of ⬎21 mmHg or ⬍5 mmHg for two or more visits or reoperation for glaucoma. All surgical procedures were performed by one of five glaucoma specialists at two tertiary care institutions. A similar operative technique was used in all patients. A fornix-based flap of conjunctiva and Tenon’s capsule was raised in the superotemporal quadrant. The lateral and superior rectus muscles were sequentially isolated using muscle hooks, and a wing of the BGI (BG101-350) was placed under each muscle belly. The implant was then secured to the sclera using two interrupted sutures. The tube was ligated in a watertight fashion near the tube–plate junction using a 7-0 polyglactin suture. One to three fenestrations were made in the tube proximal to the ligation suture in some patients using a TG 160 needle (Ethicon, Somerville, NJ). The cataract was then removed by means of a standard clear corneal phacoemulsification technique. Once this was completed, the corneal incision was closed with one or two interrupted 10-0 nylon sutures. The implant tube was trimmed to an appropriate length and inserted into the anterior chamber through a 23-gauge needle track. A piece of donor cornea, sclera, or dura mater was used to cover the limbal portion of the tube. The conjunctiva and Tenon’s capsule were reapproximated to the limbus. Subconjunctival injections of dexamethasone (Decadron) and antibiotic were given. Topical antibiotics were prescribed four times per day for 1 week, and topical steroids were used four to eight times per day for 6 to 8 weeks and tapered at the surgeon’s discretion. Results are presented as mean ⫾ standard deviation with median and range where indicated. Preoperative and postoperative mean IOP and mean number of glaucoma medications were compared using paired sample Student’s t tests. Kaplan-Meier survival analysis was also performed. Before reviewing the data, success was defined as IOP ⱖ 5 or ⱕ 21 mmHg with or without glaucoma medications and no need for additional glaucoma surgery. Patients with transient IOP elevation that responded to medical therapy were considered successes.
Results Combined phacoemulsification, IOL implantation, and Baerveldt glaucoma drainage implant surgery was performed in 77 eyes at the two institutions. Of these, three eyes were excluded, because surgery was being performed on the second eye of the same patient. Five eyes were excluded secondary to placement of a drainage device other than a BGI. Twenty-eight eyes were excluded because an additional procedure (e.g., penetrating keratoplasty or PPV) was performed at the same time as the combined CE/BGI. Eight eyes were excluded for insufficient length of follow-up. Thus, a total of 33 eyes of 33 patients were identified as meeting inclusion/exclusion criteria. Demographic data are shown in Table 1. The average age at time of surgery was 65.6 years, with a range of 28 to 84 years. Gender and race distribution were roughly equal. Race information on one patient was unknown. Nineteen right eyes were included. The most commonly used IOL was the Alcon acrylic MA60BM (Fort Worth, TX) (18 of 33, 55%). A Staar silicone foldable posterior chamber IOL (Monrovia, CA) was implanted in 7 of 33 eyes (21%), whereas an Alcon polymethyl methacrylate posterior chamber IOL was used in 6 of 33 eyes (18%). In one eye each, an Alcon acrylic posterior chamber MA30BA and Alcon polymethyl methacrylate anterior chamber MTA3UO was placed.
Table 1. Demographic Characteristics Characteristic Age (yrs, mean ⫾ standard deviation) Gender Male Female Race Nonhispanic white Black Hispanic Eye Right Left
65.6 ⫾ 13.9 16 (48%) 17 (52%) 10 (30%) 10 (30%) 12 (36%) 19 (58%) 14 (42%)
Indications for placing a BGI at the time of cataract surgery are listed in Table 2. The most common indication was a history of failed trabeculectomy in 19 of 33 eyes (58%). In addition, 3 of 33 eyes (9%) had a diagnosis of iridocorneal endothelialization syndrome, and 3 of 33 (9%) had complications from a previous trabeculectomy, including a chronic bleb leak in one patient and blebitis in two patients. Although the bleb leak persisted until the combined CE/BGI surgery was performed, the two cases of blebitis resolved with treatment before surgery. Patients were followed for an average of 15.4 months (standard deviation, 9.4), with a median of 13.1 months and a range of 3.0 to 46.9 months. A summary of visual acuity outcomes is shown in Table 3. Improvement in visual acuity from the preoperative level occurred in 20 of 33 eyes (61%). The visual acuity of five patients was unchanged postoperatively. Two patients had poor visual acuity preoperatively (hand motions, 20/400) secondary to scleral perforation and aniridic glaucoma, respectively. Another patient developed postoperative cystoid macular edema that limited her visual acuity to 20/60 at 6 Table 2. Indication for Combined Baerveldt Glaucoma Drainage Implant/Cataract Extraction Number of Eyes (%)*
Indication Failed trabeculectomy Iridocorneoendothelial syndrome Chronic angle-closure glaucoma Blebitis Chronic bleb leak Posterior blepharitis Neovascular glaucoma Aniridia Scleral perforation after radiation therapy Failed viscocanalostomy Increased IOP with corneal graft rejection
19 (58) 3 (9) 2 (6) 2 (6) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3) 1 (3)
* n ⫽ 33. IOP ⫽ intraocular pressure.
Table 3. Visual Acuity Outcomes Visual Acuity
Preoperative (%)
Last Follow-up (%)
20/20–20/40 20/50–20/100 ⬍20/100
0/33 (0) 10/33 (30.3) 23/33 (69.7)
12/33 (36.4) 8/33 (24.2) 13/33 (39.4)
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Ophthalmology Volume 109, Number 10, October 2002 Table 4. Intraocular Pressure at Specified Times Visit
Mean Intraocular Pressure
Standard Deviation
Preoperative 3 mos 6 mos 12 mos 18 mos Last follow-up
21.7 11.8 11.9 11.8 13.1 13.1
7.3 5.1 4.8 4.4 3.2 3.5
Table 5. Number of Medications Necessary to Control Intraocular Pressure P Value* ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
Visit
Mean No. of Medications
Standard Deviation
P Value*
Preoperative 3 mos 6 mos 12 mos 18 mos Last follow-up
2.3 0.5 0.7 1.0 0.4 0.7
1.0 0.9 1.0 1.4 0.7 1.1
⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001
* Paired Student’s t-test. * Paired Student’s t-test
months. The visual acuity of another patient remained 20/400 postoperatively because of hypotony-induced choroidal effusions. This patient was considered a failure, because drainage of the choroidal effusions with Baerveldt exchange was necessary 1 year after the initial surgery. The visual acuity after the second procedure, however, improved to 20/100. The visual acuity of the remaining patient failed to improve secondary to glaucoma involving fixation. Intraoperative or postoperative lens dislocation occurred in three of the eyes that had visual loss. One patient’s visual acuity decreased from 20/200 to hand motions 6 weeks after surgery complicated by a capsular rupture without vitreous loss. This patient developed aqueous misdirection and underwent PPV with IOL repositioning. The visual acuity remained hand motions at last follow-up (8 months postoperative). Intraoperative dislocation of the lens developed in another patient because of a zonular dehiscence leading to an anterior vitrectomy with placement of an anterior chamber IOL. This patient underwent PPV with removal of retained lens fragments 1 week postoperatively, and the visual acuity decreased from hand motions preoperatively to light perception, where it remained until the last follow-up at 18 months. Another patient’s visual acuity dropped from 20/400 to hand motions after intraoperative lens dislocation. A subsequent PPV was performed to remove the retained lens fragments, and a posterior chamber IOL was placed in the sulcus. The postoperative decline in visual acuity was secondary to glaucomatous progression, leading to loss of fixation. Two eyes had very poor vision preoperatively, in part secondary to the lens opacity and in part because of other factors. The visual acuity of one patient with choroidal effusions decreased from finger counting preoperatively to hand motions at 6 months, where it remained even after drainage of the choroidal effusions. Another patient with neovascular glaucoma secondary to a hemiretinal vein occlusion had a cataract, precluding administration of panretinal photocoagulation. This patient lost 1 line of vision at the 1-year follow-up compared with preoperatively. Three patients experienced decreased visual acuity to the level of finger counting postoperatively because of corneal edema. In all three patients, the onset of the corneal edema was delayed, occurring 6, 12, and 13 months postoperatively. In all cases, the corneal edema was diffuse. Two of these patients underwent penetrating keratoplasty with (n ⫽ 1) or without (n ⫽ 1) revision of the tube, and one of these recovered vision to 20/200 (the same acuity as before CE/BGI). Tables 4 and 5 show mean IOPs and number of glaucoma medications used preoperatively and postoperatively at months 3, 6, 12, and 18, and at last follow-up. A statistically significant difference was found in both the reduction in IOP and in the number of medications used at all points during follow-up. Three patients met our criteria for failure. The first, mentioned earlier, had intraoperative complications related to the cataract
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surgery and later developed aqueous misdirection with an IOP of 42. He underwent a PPV/IOL repositioning at 6 weeks postoperative for the same. A second patient failed at 6 months because of sustained elevated IOP. The third patient has also been mentioned previously. She failed at 1 year secondary to hypotony and choroidal effusions and underwent a glaucoma reoperation at that time. The Kaplan-Meier survival curve is shown in Figure 1. Of the 33 eyes that underwent combined CE and BGI surgery, our cumulative survival of the Baerveldt glaucoma implant was 94% at 6 months, 94% at 12 months, and 89% at 18 months. Table 6 lists the operative, early postoperative, and late postoperative complications, excluding eyes considered failures, the courses of which were mentioned previously. Operative complications all occurred during the cataract portion of the surgery. Of the two instances of postoperative choroidal effusions, one occurred in an eye that had intraoperative zonular dehiscence with retained lens fragments. A PPV with removal of retained lens fragments and drainage of choroidal effusions was performed 1 week later. In the other patient, the choroidals were drained at 5 months postoperative. One eye experienced retraction of the BGI tube that was repositioned at 2 months. This same eye developed corneal edema and had a second tube repositioning combined with a penetrating keratoplasty at 15 months after the initial surgery. Two other eyes developed corneal edema at 12 and 13 months postoperatively.
Figure 1. Cumulative proportion successful (intraocular pressure ⱖ 5 and ⱕ 21 mmHg with or without glaucoma medications and no need for glaucoma reoperation) after combined cataract extraction and Baerveldt implant. Hash marks represent time of last follow-up visit.
Hoffman et al 䡠 Combined Cataract Extraction and Baerveldt Drainage Implant Table 6. Operative and Postoperative Complications Complication Capsular rent (patient developed aqueous misdirection 6 wks postoperative) Zonular dehiscence with lens fragments in vitreous Lens dislocation Vitreous prolapse alone Choroidal effusion with IOP ⱖ5 Retraction of BGI tube Recurrent iritis Cystoid macular edema Corneal edema Fibrin plugging BGI tube ostium Macular striae in absence of hypotony
Timing of Occurrence
Number of Eyes
Intraoperative
1
Intraoperative
1
Intraoperative Intraoperative 1 wk, 3 mos postoperative 2 mos postoperative 1–3 mos postoperative 6 mos postoperative 6 mos, 12 mos, 13 mos postoperative 12 mos postoperative 18 mos postoperative
1 1 2 1 1 1 3 1 1
BGI ⫽ Baerveldt glaucoma drainage implant; IOP ⫽ intraocular pressure.
One of these underwent a penetrating keratoplasty at 20 months. In another eye, fibrin was noted to be blocking the tube ostium without causing elevation of IOP. This fibrin was needled at 12 months without complication or recurrence.
Discussion Combined CE and trabeculectomy has become increasingly common in treating glaucoma patients afflicted with lens opacities. The long-term success of this procedure in terms of IOP control and improvement in visual acuity has been well documented.11–13 Addressing IOP control, Yu’s group11 found no statistically significant difference after a mean of 21 months follow-up between eyes that had undergone combined extracapsular CE with IOL implantation and trabeculectomy versus eyes that had undergone trabeculectomy alone. This success rate may even be improved in patients who undergo small-incision cataract surgery along with trabeculectomy or with the adjunctive use of antimetabolites.12,14,15 Situations exist, however, in which performing a trabeculectomy at the same time as cataract surgery may not be desirable, such as a history of failed trabeculectomy, secondary glaucoma, or previous bleb-associated complication. Whereas bleb-related infections are severe and visually devastating complications of trabeculectomy, infection related to a glaucoma drainage device seems to be a rare occurrence16 and seems to occur only after exposure of the device.17 The patients in our cohort tended to have more complicated or refractory types of glaucoma, many of them having failed at least one prior glaucoma procedure. Even so, our study reveals a statistically significant decrease in IOP and number of glaucoma medications used at all points during follow-up. Our cumulative success of the BGI at 18 months was 89%, comparable to that of combined phacotrabeculectomy.12,18
Budenz et al12 have reported a 1-year cumulative success of phacotrabeculectomy with mitomycin-C to be 90% and with 5-fluorouracil to be slightly greater than 72% using success criteria identical to that in this study. Mamalis et al18 reported that 81% of patients had an IOP ⱕ 19 mmHg after 18 months of follow-up. Although IOP control in this study was similar to that found with phacotrabeculectomy, the visual acuity results were worse. Sixty-one percent of our patients experienced at least 1 line of improvement in Snellen acuity compared with preoperatively, with only 36% having a visual acuity of 20/40 or better. Carlson et al19 reported a postoperative visual acuity of ⱖ 20/40 in 27 of 29 eyes that underwent combined phacotrabeculectomy either with or without mitomycin-C, and Cohen et al20 found a postoperative visual acuity of ⱖ 20/40 in at least 85% of eyes. The poorer visual acuity results in this study are in large part secondary to preexisting ocular conditions that limited visual recovery independent of the cataract. In this study, 3 of 33 eyes (9%) developed corneal edema. The etiology in at least one case was most likely endothelial cell injury during phacoemulsification, an entity that has been well described.21,22 Another possibility is that the BGI tube caused direct endothelial damage.16,23 Even though our incidence of corneal edema is not negligible, it is much lower than that found by Bhattacharyya’s group.24 They reported the outcomes of eyes with functioning glaucoma drainage implants that subsequently underwent CE with IOL placement. In these eyes, there was no significant increase in IOP or number of medications necessary to control the glaucoma after the CE, but 3 of 11 eyes (27%) developed postoperative corneal edema, one of which experienced loss of IOP control. Although the etiology of the corneal edema in their study could have been related to endothelial cell injury during phacoemulsification or secondary to the drainage tube itself, it is certainly conceivable that repeated endothelial cell injury from multiple surgical procedures could have caused the corneal decompensation. In such eyes, it might be preferable to perform the CE and BGI at the same time. To our knowledge, this study is the first report of the surgical outcomes of combined CE/BGI. Although it suffers from its retrospective design and lack of randomization to different treatment groups, it describes a new option in combined surgery for a select group of difficult patients, in most of whom phacotrabeculectomy would be at high risk for failure. Understanding the limitations of this study, it seems that combined CE/BGI is a safe and effective approach in treating patients with cataract and glaucoma and may be an option in combined cases at high risk for failure of trabeculectomy.
References 1. Rockwood EJ, Parrish RK III, Heuer DK, et al. Glaucoma filtering surgery with 5-fluorouracil. Ophthalmology 1987;94: 1071– 8. 2. Krishna R, Godfrey DG, Budenz DL, et al. Intermediate-term
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4.
5. 6. 7. 8. 9. 10. 11.
12. 13.
14. Joos KM, Bueche MJ, Palmberg PF, et al. One-year follow-up results of combined mitomycin C trabeculectomy and extracapsular cataract extraction. Ophthalmology 1995; 102:76 – 83. 15. Lederer CM Jr. Combined cataract extraction with intraocular lens implant and mitomycin-augmented trabeculectomy. Ophthalmology 1996;103:1025–34. 16. Nguyen QH, Budenz DL, Parrish RK II. Complications of Baerveldt glaucoma drainage implants. Arch Ophthalmol 1998;116:571–5. 17. Gedde SJ, Scott IU, Tabandeh H, et al. Late endophthalmitis associated with glaucoma drainage implants. Ophthalmology 2001;108:1323–7. 18. Mamalis N, Lohner S, Rand AN, Crandall AS. Combined phacoemulsification, intraocular lens implantation, and trabeculectomy. J Cataract. Refract Surg 1996;22:467–73. 19. Carlson DW, Alward WLM, Barad JP, et al. A randomized study of mitomycin augmentation in combined phacoemulsification and trabeculectomy. Ophthalmology 1997;104:719 – 24. 20. Cohen JS, Greff LJ, Novack GD, Wind BE. A placebocontrolled, double-masked evaluation of mitomycin C in combined glaucoma and cataract procedures. Ophthalmology 1996;103:1934 – 42. 21. Kohlhaas M, Klemm M, Kammann J, Richard G. Endothelial cell loss secondary to two different phacoemulsification techniques. Ophthalmic Surg Lasers 1998;29:890 –5. 22. Hayashi K, Hayashi H, Nakao F, Hayashi F. Risk factors for corneal endothelial injury during phacoemulsification. J Cataract Refract Surg 1996;22:1079 – 84. 23. Zalloum JN, Ahuja RM, Shin D, Weiss JS. Assessment of corneal decompensation in eyes having undergone Molteno shunt procedures compared to eyes having undergone trabeculectomy. CLAO J 1999;25:57– 60. 24. Bhattacharyya CA, WuDunn D, Lakhani V, et al. Cataract surgery after tube shunts. J Glaucoma 2000;9:453–7.
1. 2. 3. 4. 5. 6.
3.
outcomes of 350-mm2 Baerveldt glaucoma implants. Ophthalmology 2001;108:621– 6. Huang MC, Netland PA, Coleman AL, et al. Intermediateterm clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol 1999;127:27–33. Lloyd MA, Baerveldt G, Fellenbaum PS, et al. Intermediateterm results of a randomized clinical trial of the 350- versus 500-mm2 Baerveldt implant. Ophthalmology 1994;101:1456 – 63; discussion 1463– 4. Mills RP, Reynolds A, Emond MJ, et al. Long-term survival of Molteno glaucoma drainage devices. Ophthalmology 1996; 103:299 –305. Perkins TW, Gangnon R, Ladd W, et al. Molteno implant with mitomycin C: intermediate-term results. J Glaucoma 1998;7: 86 –92. Price FW Jr, Wellemeyer M. Long-term results of Molteno implants. Ophthalmic Surg 1995;26:130 –5. Siegner SW, Netland PA, Urban RC Jr, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology 1995;102:1298 –307. Smith MF, Doyle JW, Sherwood MB. Comparison of the Baerveldt glaucoma implant with the double-plate Molteno drainage implant. Arch Ophthalmol. 1995;113. 444 –7. Topouzis F, Coleman AL, Choplin N, et al. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol 1999;128:198 –204. Yu CBO, Chong NHV, Caesar RH, et al. Long-term results of combined cataract and glaucoma surgery versus trabeculectomy alone in low-risk patients. J Cataract Refract Surg 1996; 22:352–7. Budenz DL, Pyfer M, Singh K, et al. Comparison of phacotrabeculectomy with 5-fluorouracil, mitomycin-C, and without antifibrotic agents. Ophthalmic Surg Lasers 1999;30:367–74. Yamagami S, Hamada N, Araie M, Shirato S. Risk factors for unsatisfactory intraocular pressure control in combined trabeculectomy and cataract surgery. Ophthalmic Surg Lasers 1997;28:476 – 82.
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