Don S. Minckler

Which Is Better? One or Two?: A Randomized Clinical Trial of Single-plate versus Double-plate Molteno Implantation for Glaucomas in Aphakia and Pseudophakia

PURPOSE Previous studies have suggested that primary double-plate Molteno implantation may be beneficial. Therefore, the authors performed a randomized clinical trial to evaluate the relative effectiveness and safety of single- versus double-plate Molteno implantation. METHODS From March 1988 to February 1990, 132 patients who underwent Molteno implantation for medically uncontrollable non-neovascular glaucomas in aphakia or pseudophakia were randomly assigned to receive either single- or double-plate implants. RESULTS The 1- and 2-year life-table success rates (success [survival] defined as 6 mmHg < or = final intraocular pressure [IOP] < or = 21 mmHg without additional glaucoma surgery or devastating complication) were 55% and 46% with single-plate implantation and 86% and 71% with double-plate implantation, respectively. The final postoperative visual acuities were within one line of the preoperative visual acuities or had improved in 73% and 80% of patients, respectively. Choroidal hemorrhages and/or effusions, corneal decompensation, flat anterior chambers, and phthisis bulbi were more common in the patients who had undergone double-plate Molteno implantation; however, transient elevations of IOP during the first few postoperative months were more common in the patients who had undergone single-plate Molteno implantation. CONCLUSIONS Double-plate Molteno implantation more frequently affords IOP control than single-plate Molteno implantation; however, double plates are associated with greater risks of choroidal hemorrhages and/or effusions, corneal decompensation, flat anterior chambers, and phthisis bulbi.

Aqueous Shunts in Glaucoma: A Report by the American Academy of Ophthalmology

OBJECTIVE To provide an evidence-based summary of commercially available aqueous shunts currently used in substantial numbers (Ahmed [New World Medical, Inc., Rancho Cucamonga, CA], Baerveldt [Advanced Medical Optics, Inc., Santa Ana, CA], Krupin [Eagle Vision, Inc, Memphis, TN], Molteno [Molteno Ophthalmic Ltd., Dunedin, New Zealand]) to control intraocular pressure (IOP) in various glaucomas. METHODS Seventeen previously published randomized trials, 1 prospective nonrandomized comparative trial, 1 retrospective case-control study, 2 comprehensive literature reviews, and published English language, noncomparative case series and case reports were reviewed and graded for methodologic quality. RESULTS Aqueous shunts are used primarily after failure of medical, laser, and conventional filtering surgery to treat glaucoma and have been successful in controlling IOP in a variety of glaucomas. The principal long-term complication of anterior chamber tubes is corneal endothelial failure. The most shunt-specific delayed complication is erosion of the tube through overlying conjunctiva. There is a low incidence of this occurring with all shunts currently available, and it occurs most frequently within a few millimeters of the corneoscleral junction after anterior chamber insertion. Erosion of the equatorial plate through the conjunctival surface occurs less frequently. Clinical failure of the various devices over time occurs at a rate of approximately 10% per year, which is approximately the same as the failure rate for trabeculectomy. CONCLUSIONS Based on level I evidence, aqueous shunts seem to have benefits (IOP control, duration of benefit) comparable with those of trabeculectomy in the management of complex glaucomas (phakic or pseudophakic eyes after prior failed trabeculectomies). Level I evidence indicates that there are no advantages to the adjunctive use of antifibrotic agents or systemic corticosteroids with currently available shunts. Too few high-quality direct comparisons of various available shunts have been published to assess the relative efficacy or complication rates of specific devices beyond the implication that larger-surface-area explants provide more enduring and better IOP control. Long-term follow-up and comparative studies are encouraged.

Glaucoma associated with uveitis

Raised intraocular pressure is a common and frequently serious complication of anterior uveitis. The milieu of inflammatory cells, the mediators they release, and the corticosteroid therapy used to treat the uveitis can participate in the pathogenesis of uveitic glaucoma. These factors alter the normal anatomic structure of the anterior chamber and angle, influencing aqueous production and outflow. These changes act to disrupt the homeostatic mechanisms of intraocular pressure control. Structural changes in the angle can be acute, such as in secondary angle closure with pupillary block glaucoma, or chronic, such as combined steroid-induced and secondary open angle glaucoma. Management of uveitic glaucoma may be difficult because of the numerous mechanisms involved in its pathogenesis. Diagnostic and therapeutic decisions are guided by careful delineation of the pathophysiology of each individual case. The goal of treatment is to minimize permanent structural alteration of aqueous outflow and to prevent damage to the optic nerve head. This article reviews the pathogenesis of uveitic glaucoma, with specific attention to etiology. Medical and surgical therapies are also discussed, with emphasis on the more recent developments in each category.

Molteno Implantation for Glaucoma in Young Patients

Seventy patients younger than 21 years of age underwent Molteno implantation for nonneovascular glaucoma. Fifty-three (76%) patients had failed angle and/or conventional filtering surgery. Final intraocular pressure less than 22 mmHg (but over 5 mmHg) was achieved in 40 (62%) of the 65 patients with at least 6-month follow-up (range, 6 to 59 months; mean +/- standard deviation, 22.7 +/- 14.1 months); however, only 22 (34%) were controlled after the initial Molteno implantation procedure, and 54 (83%) patients underwent further glaucoma and/or nonglaucoma surgical procedures. The visual acuities remained within one line of their preoperative levels or improved in 25 (68%) of the 37 patients on whom Snellen acuities were available. The most frequent complications included: tube-cornea touch (20%, transient in 3%), corneal edema (17%), retinal detachment (16%), tube block (10%), cataract (9%), chronic hypotony or phthisis (9%), pupillary or cyclitic membrane (9%), hyphema (7%), flat anterior chamber (6%), and large postoperative choroidal effusion (6%). Despite the high rates of subsequent surgical interventions and complications, Molteno implantation has been a useful approach for achieving intraocular pressure reduction in young patients with glucoma.

Clinical experience with the single-plate Molteno implant in complicated glaucomas. Update of a pilot study.

Ninety-six patients who had undergone single-plate Molteno implantation for glaucomas with poor surgical prognoses were re-evaluated for long-term results. Control of intraocular pressure was achieved with one single-plate implant to a level less than 22 mmHg (but greater than 5 mmHg) without reoperation or devastating complications in 46% of the aphakic/pseudophakic eyes, 25% of eyes after failed filters, 25% of eyes with neovascular glaucomas, and 26% of eyes in patients younger than 13 years of age (life-table analysis at 5 years). Five-year success rates improved to 53%, 71%, 40%, and 56%, respectively, when data from second plates were included. Visual acuities improved or remained the same after one or two plates were implanted in 47% of aphakic/pseudophakic eyes, 17% of eyes after failed filters, 65% of eyes with neovascular glaucomas, and 63% of eyes in patients younger than 13 years of age on whom Snellen acuity was available. The most frequent overall complications after implantation of one or two plates included: corneal edema (19%), corneal graft decompensation (13%), and cornea-tube touch, retinal detachment, and cataract (8% each).

Intermediate-term Results of a Randomized Clinical Trial of the 350- versus- the 500-mm2 Baerveldt Implant

BACKGROUND The Baerveldt glaucoma implant is a large equatorial aqueous shunting device that is installed through a single-quadrant conjunctival incision. The intermediate-term results of a randomized study comparing the 350- and 500-mm2 Baerveldt implants are reported. METHODS Seventy-three patients with medically uncontrollable, nonneovascular glaucomas associated with aphakia, pseudophakia, or failed filters were enrolled in a randomized, prospective study comparing 350- and 500-mm2 Baerveldt implants. Surgical success was defined as 6 mmHg < or = final intraocular pressure < or = 21 mmHg without glaucoma reoperation or devastating complication. RESULTS Of patients with 350- and 500-mm2 implants, 93% and 88%, respectively, achieved surgical success (18-month life-table analysis, P = 0.93). The 500-mm2 implants afforded intraocular pressure control with significantly fewer medications (0.7 versus 1.3; P = 0.006). The postoperative visual acuities remained within one line of the preoperative visual acuities or improved in 62% and 66% of patients in the 350- and 500-mm2 groups, respectively (P = 0.93). Complication rates were statistically similar. The most frequent ones in the 350- and 500-mm2 groups, respectively, were serous choroidal effusion (16% and 32%), strabismus (16% and 19%), anterior uveitis (14% and 11%), and corneal or corneal graft edema (11% each). CONCLUSION The intermediate-term results of the 350- and 500-mm2 Baerveldt implants were statistically comparable with respect to surgical and visual outcomes, as well as complications, although the larger implant was associated with a higher rate of some complications. However, the 500-mm2 Baerveldt implant afforded intraocular pressure control with fewer medications than the 350-mm2 implant.

Optic nerve damage in glaucoma

Abstract Ladies and gentlemen, our case rests. I do not contend that ischemia is the sole mechanism by which the optic nerve becomes damaged in glaucoma. But can one seriously doubt that it plays an important role?

Experience with the Baerveldt Glaucoma Implant in Treating Neovascular Glaucoma

PURPOSE The authors present a retrospective study designed to assess the effectiveness of the Baerveldt glaucoma implant in controlling intraocular pressure (IOP) and maintaining visual function in eyes with neovascular glaucoma. METHODS The medical records of all 36 patients (36 eyes) who underwent Baerveldt glaucoma implantation for medically uncontrolled neovascular glaucoma between February 1991 and December 1992 were reviewed. RESULTS Eighteen patients received Model 350 implants, 16 received Model 500 implants, and 2 received Model 200 implants. The 12- and 18-month life-table success rates (success defined as 6 mmHg < or = final IOP < or = 21 mmHg without additional glaucoma surgery or devastating complication) were 79% and 56%, respectively. Visual acuity remained stable or improved in 10 (31%) patients. Postoperative complications included flat anterior chamber, serous choroidal detachment, and obstruction of the proximal tube tip with fibrovascular tissue, each of which occurred in four (11%) patients. Eleven (31%) patients lost light perception. There were no significant differences between the groups receiving the Model 350 and Model 500 implants with respect to life-table success rates, percentage of postoperative IOP reduction, or complication rates. Patients in the Model 500 implant group required significantly fewer antiglaucoma medications post-operatively, but also demonstrated a significantly greater mean visual acuity reduction. Better preoperative visual acuity and increased patient age were positively correlated with a successful outcome. CONCLUSIONS Baerveldt implantation is effective in controlling IOP elevation associated with neovascular glaucoma. Postoperative visual loss, despite adequate IOP control, is common. Young patient age and poorer preoperative visual acuity are significant predictors of surgical failure.

Initial Clinical Experience with the Baerveldt Implant in Complicated Glaucomas

BACKGROUND The Baerveldt glaucoma implant is an aqueous shunting device with a large surface area that is installed through a conjunctival incision in one quadrant of the eye. This study presents the initial results of the first 13 patients who underwent Baerveldt implantation as part of the Food and Drug Administration approval process. METHODS Thirteen patients with medically uncontrollable complicated glaucomas underwent one-stage implantation of either a 200- or 350-mm2 Baerveldt implant without postoperative systemic antifibrosis therapy. Surgical success was defined as intraocular pressure greater than or equal to 6 and less than or equal to 21 mmHg without glaucoma reoperation or devastating complication. RESULTS Eight patients (62%) had successful surgical outcomes, with a mean follow-up of 17.3 +/- 7.0 months (+/- standard deviation) (range, 6-24 months). Seven (70%) of the ten patients with glaucomas associated with aphakia or pseudophakia had successful outcomes, whereas only one (50%) of the two patients with neovascular glaucomas had a successful outcome. One patient with glaucoma associated with nanophthalmos and an unsuccessful filtering procedure had a failed outcome. The postoperative visual acuities remained within one line of the preoperative visual acuities or improved in 62% of the patients. The most frequent complications among all patients were transient serous choroidal effusion (23%) and hyphema (15%). CONCLUSION Initial results of the Baerveldt implant generally are comparable with other implants. It is easier to install and requires less extensive conjunctival dissection than other large implants. Additional studies are needed to evaluate the effectiveness of the Baerveldt implant in affording long-term intraocular pressure control.

In Vitro and In Vivo Flow Characteristics of Glaucoma Drainage Implants

PURPOSE To determine pressure-flow characteristics at physiologic flow rates in vitro and in vivo in rabbits for Ahmed, Baerveldt, Krupin disk, and OptiMed glaucoma implants. The Molteno dual-chamber implant also was evaluated in vivo only. METHODS Five samples of each glaucoma implant were studied. Baerveldt implants were ligated partially for in vitro testing. Opening and closing pressures in air or after immersion in balanced salt solution or plasma were evaluated for the valved devices (Ahmed and Krupin). Pressures were measured in vitro and in vivo in normal rabbits at flow rates preset at between 2 and 25 microliters/minute after the tubes were connected to a closed manometric system. In vivo measurements were made 24 hours after implantation. Resistance to flow was calculated using Poiseuilles equation after at least three separate flow rate readings. RESULTS In air, the Ahmed and Krupin valves had opening pressures of 9.2 +/- 3.4 and 7.2 +/- 0.6 mmHg and closing pressures of 5.2 +/- 0.9 and 3.9 +/- 1 mmHg, respectively. Neither opening nor closing pressures could be determined when Ahmed and Krupin valves were immersed. In vitro, the Ahmed and OptiMed devices had higher pressures than did other devices at a 2-microliters/minute flow rate of balanced salt solution. During perfusion with plasma, only the OptiMed device maintained higher pressures than with balanced salt. With all devices, pressures fell rapidly to zero after flow was stopped. The OptiMed device demonstrated the highest resistance values. In vivo, the Ahmed device provided pressures of 7.5 +/- 0.8 mmHg and the OptiMed device gave pressures of 19.6 +/- 5.6 mmHg at a 2-microliters/minute flow rate. After 15 minutes of flow shutdown, the OptiMed implant maintained pressures of 7.1 +/- 1.1 mmHg. The Baerveldt (nonligatured), Krupin, and Molteno dual-chamber implants had similar resistances and pressures in vivo. Pressures with all devices in vivo fell rapidly to zero after conjunctival wound disruption. CONCLUSION Neither the Ahmed nor Krupin devices had demonstrable opening or closing pressures when tested in vitro immersed in balanced salt solution or plasma. With all devices, pressures were higher in vivo than in vitro due to tissue-induced resistance around the explant. Both Ahmed and Krupin valves functioned as flow-restricting devices at the flow rates studied, but did not close after initial perfusion with fluid.