Postoperative systemic corticosteroid treatment and Molteno implant surgery: a randomized clinical trial. A prospective, comparative study between endoscopic cyclophotocoagulation and the Ahmed drainage implant in refractory glaucoma. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Partial Tenon's capsule resection with adjunctive mitomycin C in Ahmed glaucoma valve implant surgery. Comparison of the double-plate Molteno drainage implant with the Schocket procedure. Aqueous shunts. Molteno versus Schocket. The effect of surface area expansion with pericardial membrane (preclude) in Ahmed glaucoma valve implant surgery. Efficacy and safety of adjunctive mitomycin C during Ahmed Glaucoma Valve implantation: a prospective randomized clinical trial. Ahmed glaucoma valve implant vs trabeculectomy in the surgical treatment of glaucoma: a randomized clinical trial. Prevention of early postoperative hypotony by partial ligation of silicone tube in Ahmed glaucoma valve implantation. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. The effect of mitomycin C on Molteno implant surgery: a 1-year randomized, masked, prospective study. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. A comparison of postoperative complications from pressure-ridge Molteno implants versus Molteno implants with suture ligation. [Long-term follow-up study on Hunan aqueous drainage implantation combined with mitomycin C for refractory glaucoma].
To determine whether it is possible to improve the surgical success of Molteno implantation by causing a general suppression of collagen synthesis with postoperative oral prednisolone.
                Twenty-two patients requiring single stage, single-plate Molteno implantation were randomized into two study groups: the control group A and the systemic prednisolone treatment group B. Serum markers of collagen metabolism were monitored.
                A successful outcome at the end of the 6-month follow-up, defined as final IOP > or =6 mmHg and < or =22 mmHg with less or equal number of antiglaucoma medication as preoperatively and no additional surgery was achieved in 9 of 11 (82 %) patients of group A and in 5 of 10 (50 %) patients of group B (p= 0.18). There was a statistically significant decrease in serum markers of collagen synthesis in the group B but not in the group A.
                The serum markers indicated a systemic effect of oral prednisolone on collagen synthesis in group B but it did not improve the surgical outcome as compared to the controls. To compare endoscopic cyclophotocoagulation (ECP) and the Ahmed drainage implant in the treatment of refractory glaucoma.
                Sixty-eight eyes of 68 patients with refractory glaucoma were prospectively assigned to either ECP or Ahmed tube shunt implantation. All procedures were performed by a single surgeon. Eyes that were included were pseudophakic with a history of at least one trabeculectomy with antimetabolite, an intraocular pressure (IOP) equal to or above 35 mm Hg on maximum tolerated medical therapy, and a visual acuity better than light perception. Exclusion criteria included eyes that had had previous glaucoma drainage device implantation or a cyclodestructive procedure. Success was defined as an IOP more than 6 mm Hg and less than 21 mm Hg, with or without topical anti-hypertensive therapy.
                The mean follow-up was 19.82 +/- 8.35 months and 21.29 +/- 6.42 months, for the Ahmed and ECP groups, respectively (P = 0.4). The preoperative IOP, 41.32 +/- 3.03 mm Hg (Ahmed) and 41.61 +/- 3.42 mm Hg (ECP) (P = 0.5), and the mean postoperative IOP, at 24 months follow-up, 14.73 +/- 6.44 mm Hg (Ahmed) and 14.07 +/- 7.21 mm Hg (ECP) (P = 0.7), were significantly different from baseline in both groups (P < 0.001). Kaplan-Meier survival curve analysis showed a probability of success at 24 months of 70.59% and 73.53% for the Ahmed and ECP groups, respectively (P = 0.7). Complications included choroidal detachment (Ahmed 17.64%, ECP 2.94%), shallow anterior chamber (Ahmed 17.64%, ECP 0.0%), and hyphema (Ahmed 14.7%, ECP 17.64%).
                There was no difference in the success rate between the Ahmed Glaucoma Valve and ECP in refractory glaucoma. The eyes that underwent Ahmed tube shunt implantation had more complications than those treated with ECP. To report the longer term results of a randomized, clinical trial comparing the 350-mm2 and the 500-mm2 Baerveldt glaucoma implants.
                Extended follow-up on a randomized, controlled trial.
                Between March 1991 and April 1993, 107 patients with uncontrolled intraocular pressure (IOP) due to non-neovascular glaucoma associated with aphakia, pseudophakia, or failed filters were randomly assigned for surgical placement of either the 350-mm or the 500-mm2 Baerveldt implant at the Doheny Eye Institute.
                A random-numbers table was used to assign each patient to one of the two groups. Preoperative IOPs and visual acuities were recorded. Clinical records were reviewed to ascertain postoperative IOPs, visual acuities, number of medications used, and implant-related complications that occurred throughout the follow-up period.
                Success was defined as IOP of 6 mmHg or greater and of 21 mmHg or less in two or more consecutive follow-up visits without further glaucoma surgery or loss of light perception attributable to glaucoma.
                The overall success rates were 87% for the 350-mm2 group and 70% for the 500-mm2 group (P = 0.05). Average follow-up was 37 months (range, 1-76 months) for the 350-mm2 group and 34 months (range, 5-77 months) for the 500-mm2 group. The life-table success rates declined over time for both implant groups, from a high of 98% for the 350-mm2 group and 92% for the 500-mm2 group at 1 year to a cumulative success rate of 79% for the 350-mm2 group and 66% for the 500-mm2 group at 5 years. Visual acuities were better or remained the same in 50% of the patients in the 350-mm2 group and 46% of those in the 500-mm2 group. Complications during the 5-year follow-up were also statistically similar.
                The longer term results show that the 350-mm2 Baerveldt implant is more successful than the 500-mm2 implant for overall IOP control. Interval comparisons indicate a higher rate of success for the 350-mm2 implant in the first, second, third, fourth, and fifth years of implantation. Visual acuities, implant-related complications, and average IOPs were statistically indistinguishable between the two groups. To verify if partial intraoperative Tenon's capsule resection (PTCR) with adjunctive mitomycin C is effective in developing thin, avascular blebs in eyes undergoing Ahmed glaucoma valve insertion, and to assess the efficacy and safety of this procedure.
                A multicentre, prospective, alternating case assignment, investigator unmasked, parallel group, comparative interventional study was conducted in four Latin American countries (Argentina, Brazil, Colombia, and Peru). Ahmed glaucoma valve implant insertion with PTCR (group A) and without PCTR (group B) was performed in neovascular glaucomatous eyes without previous surgery. Adjunctive mitomycin C (MMC) was used in both groups. Patients were examined 1 day, 10 days, 1 month, 2 months, 3 months, 6 months, and 1 year following the surgery. Intraocular pressure (IOP) and the appearance of the bleb were evaluated at each examination. Appearance of the bleb was classified at both the 1 month mark and last examinations into one of three groups: flat and vascularised; elevated avascular; or elevated and not avascular.
                92 eyes from 92 patients were included in the study. The preoperative mean IOP was 50.0 (SD 10.5) mm Hg in group A and 48.4 (11.7) in group B (p>0.05). Statistically significant IOP reductions were observed at all periods of follow up. 12 months after surgery, the mean IOP was 17.2 (5.0) mm Hg in group A and 18.3 (8.7) mm Hg in group B (p>0.05). A hypertensive phase occurred in 40.0% in group A and in 46.8% in group B (p>0.05). At the 1 month and the final follow up, the blebs in all eyes were considered elevated and not avascular. The success rate (IOP</=21 mm Hg) at 1 year after surgery was 70.4% in group A and 77.7% in group B (p>0.05). Overall, 74.2% of the patients achieved an IOP </=21 mm Hg and 55.2% an IOP</=17 mm Hg, with or without additional medication administered to lower IOP. The incidence of complications was similar in both groups.
                In eyes undergoing Ahmed valve implantation for neovascular glaucoma, PCTR with MMC augmentation showed no additional benefits or complications over MMC augmentation alone; no avascular bleb was obtained with this technique. The incidence of a hypertensive phase was lower than reported in previous studies. A randomized, prospective study was undertaken to compare the results of the double-plate Molteno implant with those of the anterior chamber tube shunt to encircling band (ACTSEB) procedure, described by Schocket, for eyes with complicated glaucoma. One surgeon performed all the procedures. For statistical analysis there were 21 eyes in the ACTSEB group and 19 eyes in the Molteno group, with at least 6 months of follow-up (mean follow-up, 26 months; range, 6 to 49 months). Eyes with aphakia/pseudophakia, uveitis, previous penetrating keratoplasty, previous unsuccessful trabeculectomy, and neovascular glaucoma were evenly distributed between the two groups. Mean preoperative intraocular pressures in the ACTSEB and Molteno groups were 35.2 and 34.6 mm Hg, respectively. With the exclusion of one phthisical eye in each group final mean intraocular pressure in the ACTSEB group was 15.1 mm Hg, with a mean of 0.43 medications, and 14.4 mm Hg, with a mean of 0.95 medications, in the Molteno group. Seven (33%) of 21 eyes and 13 (68%) of 19 eyes in the ACTSEB and Molteno groups, respectively, were receiving additional antiglaucoma medication at the most recent visit (P = .027). Final visual acuity was stable (within one Snellen line of baseline visual acuity) or improved in 10 (48%) of 21 eyes in the ACTSEB group compared with 13 (68%) of 19 eyes in the Molteno group. Complications or inadequate pressure control requiring further surgical intervention were seen in nine (47%) of 19 eyes in the Molteno group and 12 (57%) of 21 eyes in the ACTSEB group.(ABSTRACT TRUNCATED AT 250 WORDS) The authors conducted a multicenter, randomized, controlled trial to test whether the Schocket shunt with a larger shunt reservoir surface area would provide a lower final intraocular pressure than the double-plate Molteno implant. However, the Molteno implant produced a statistically lower intraocular pressure at 6 months compared with the Schocket shunt. Postoperative visual acuity, glaucoma medications, and complications were not statistically different. To compare the efficacy of Ahmed glaucoma valve (AGV) implant with and without surface area expansion using pericardial membrane (Preclude) in the treatment of complicated glaucoma.
                Ten eyes of AGV implant surgery using pericardial membrane (Preclude) that were designed to have surface area of 300 mm (e-AGV group) and 10 eyes of AGV implant surgery without surface area extension (AGV group) were enrolled in this prospective, randomized controlled trial study.
                Two (20%) of 10 eyes in the e-AGV group, and 8 (80%) of 10 eyes in the AGV group experienced the hypertensive phase (P = 0.007). Complete success rate was 90% in the e-AGV group and 70% in the AGV group (P = 0.291). Mean number of preoperative antiglaucoma medication was 2.4 +/- 0.5 and 1.9 +/- 0.3 for the e-AGV and AGV groups, respectively, and that of postoperative antiglaucoma medication was 0.1 +/- 0.3 and 0.4 +/- 0.7 for the e-AGV and AGV groups, respectively, at final follow-up (P = 0.229).
                Surface area expansion with pericardial membrane (Preclude) in AGV implant surgery resulted in a statistically significantly lower rate of hypertension without causing any postoperative complications. To evaluate the efficacy and safety of intraoperative mitomycin C (MMC) in eyes undergoing Ahmed Glaucoma Valve implantation.
                Randomized controlled clinical trial.
                Sixty patients with refractory glaucoma.
                Sixty eyes of 60 patients with refractory glaucoma were randomized to receive intraoperative MMC (0.5 mg/ml for 5 minutes) (n = 34) or balanced salt solution (n = 26) during Ahmed Glaucoma Valve implantation.
                Surgical success was defined according to 2 different criteria: (1) postoperative intraocular pressure (IOP) between 6 and 21 mmHg, with or without antiglaucoma medications, and (2) IOP reduction of at least 30% relative to preoperative values. Eyes requiring additional glaucoma surgery, developing phthisis, or showing loss of light perception were classified as failures. Success rates in both groups were compared using Kaplan-Meier survival curves and the log rank test. Other outcome measures were mean IOP, number of glaucoma medications, and complications.
                After a mean follow-up of 12.3 months, Kaplan-Meier survival analysis showed a probability of success of 59% at 18 months for the MMC group and 61% for the control group when the first criterion for success was used (IOP between 6 and 21 mmHg). When an IOP reduction of at least 30% was used as the criterion to define success, the Kaplan-Meier survival analysis demonstrated a probability of success at 18 months of 62% for the MMC group and 67% for the control group. There were no significant differences in survival rates between the 2 groups with either criterion (P = 0.75 and P = 0.37, respectively). After 15 days postoperatively, the mean IOP did not significantly differ for both MMC and control eyes. Mean numbers of postoperative antiglaucoma medications were similar in MMC-treated eyes and controls. There was no significant difference between the incidences of postoperative complications in both groups.
                Mitomycin C did not increase the short- or intermediate-term success rates of Ahmed Glaucoma Valve implantation. To compare the short- and intermediate-term results of two commonly used glaucoma surgical procedures, trabeculectomy and Ahmed glaucoma valve implant.
                A randomized clinical trial was performed at two international centers. One eye each of consecutive patients requiring glaucoma surgery for intraocular pressure control was randomized to receive either trabeculectomy or the Ahmed implant.
                Of the 117 patients, 62 were randomized to trabeculectomy and 55 to the Ahmed implant. With a mean follow-up of 9.7 months, the trabeculectomy group had statistically lower intraocular pressures at weeks 6 to 15 (12.6 mm Hg vs 16.4 mm Hg) and months 11 to 13 (11.4 mm Hg vs 17.2 mm Hg) than the Ahmed implant group. Compared with preoperative status, no statistically significant differences between groups were noted for visual acuity, visual field, lens status, and final anterior chamber depth. The cumulative probabilities of success (intraocular pressure <21 mm Hg and at least 15% reduction in intraocular pressure from preoperative level) were 83.6% for trabeculectomy and 88.1% for Ahmed implant (P =.43). However, the Ahmed implant group had a greater adjunctive medication requirement. On the last visit, 10 of the trabeculectomy eyes and 19 of the Ahmed implant eyes required at least one topical medication (P =.01). There was no statistically significant difference in the rate of complications between the two groups.
                Lower mean intraocular pressures were noted for the trabeculectomy group. All other results, including success (as defined in this study) and frequency of complications, were comparable between the two groups. To determine the effectiveness of the partial ligation of a silicone tube of Ahmed glaucoma valve implantation to prevent early postoperative hypotony.
                Thirty-two Korean patients were divided into two groups. Ahmed glaucoma valve implantation was performed with or without partial ligation in 16 eyes. The incidence of complications and the success rate in each group were compared.
                In the partial-ligation group, 10 patients (62.5%) had successful intraocular pressure control (> 5 to < 22 mm Hg) without any additional antiglaucoma medications, whereas intraocular pressure in 12 patients (75.0%) was controlled with or without additional antiglaucoma medications. In the nonligation group, nine patients (56.3%) had successful intraocular pressure control without any additional medications, whereas intraocular pressure in 12 patients (75.0%) was controlled with or without additional antiglaucoma medications. Early postoperative hypotony occurred in 1 of 16 (6.3%) patients with partial ligation and 4 of 16 (25%) patients without ligation.
                The partial ligation of a tube in Ahmed glaucoma valve implantation suggested a lower rate of hypotony and surgical complications. There was no significant difference in final success rate between the partial ligation and nonligation groups. To compare the long-term results of trabeculectomy and Ahmed glaucoma valve implant in the initial surgical management of primary open- and closed-angle glaucoma.
                Randomized controlled clinical trial.
                One eye each of consecutive patients with primary glaucoma and without prior intraocular surgery was randomized to receive either trabeculectomy or the Ahmed implant. Large university-affiliated eye hospital in Columbo, Sri Lanka.
                Of 123 patients, 64 were randomized to trabeculectomy and 59 to the Ahmed implant. With a mean follow-up of 31 months, the trabeculectomy group had statistically lower intraocular pressures (IOP) during the first postoperative year. After the first year, the IOPs were comparable. No statistically significant differences between groups were noted for postoperative visual acuity, visual field, anterior chamber depth, and short-term or long-term complications. Adjunctive medication requirement was comparable for both groups. The cumulative probabilities of success (IOP <21 mm Hg and at least 15% reduction in IOP from preoperative levels) at the final follow-up period (months, 41-52) were 68.1% for trabeculectomy and 69.8% for Ahmed implant (P =.86).
                Lower IOPs were noted for the trabeculectomy group during the first year. With longer follow-up, the IOPs and the cumulative probabilities of success were comparable between the two groups. The authors assess whether adjunctive mitomycin C improves Molteno tube shunt surgery in terms of intraocular pressure (IOP), visual acuity, and complication rates.
                Twenty-five eyes of twenty-five consecutive patients undergoing double-plate Molteno implant surgery were randomized to receive either mitomycin C (MMC) 0.4 mg/mL for 2 minutes or a control balanced salt solution in a masked, prospective study. Intraocular pressure, visual acuity, and complications were recorded 1 week and 1, 3, 6, and 12 months after surgery. A repeated measures analysis of variance (ANOVA) model was used to test the overall effect of the drug on IOP and percent change from preoperative IOP.
                Thirteen eyes received balanced salt solution and 12 eyes received MMC. There was no difference between the groups with respect to age, preoperative IOP, log mean angle of resolution (LogMar) visual acuity, or number of preoperative medications. Except for week 1, there were no differences between the groups at any of the clinic visits with respect to IOP and percent change from baseline IOP. Analysis of the visual acuity (LogMar) showed reduction in vision for both groups. Complications were similar in each group, as were number of postoperative hypotensive agents required.
                Adjunct MMC does not demonstrate a significant difference in outcomes compared with placebo in pressure-ridged Molteno implant surgery. Results of this study are limited by a small number of patients in each group and a fixed dose of MMC. 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.
                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.
                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.
                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. The pressure-ridge Molteno implant incorporates a ridge on the proximal episcleral plate to limit aqueous outflow during the immediate postoperative period. This modification is intended to decrease the high incidence of postoperative hypotony and flat anterior chambers following Molteno tube implantation, while avoiding the pressure spikes that can occur with suture ligation of the Molteno tube. This study was devised to compare postoperative intraocular pressure control and complications associated with pressure-ridge Molteno implantation versus a standard Molteno implantation with suture ligation of the tube.
                Thirty eyes were prospectively randomized to receive either a pressure-ridge, double-plate Molteno implant or a standard, double-plate Molteno Molteno implant with suture ligation of the tube.
                Postoperative intraocular pressure was significantly higher at day 1 and week 2 in the suture-ligation implant group, although the final pressure at 12 weeks was not different between the two groups. Six of 15 eyes from the pressure-ridge implant group experienced shallow or flat anterior chambers with hypotony, whereas 5 of 15 eyes from the suture-ligation implant group had significant postoperative pressure spikes.
                Because the ridge effect is unpredictable, further modifications are necessary to prevent postoperative hypotony. To investigate the long-term therapeutic effect of Hunan aqueous drainage (HAD) implantation with and without adjunctive intraoperative mitomycin C (MMC) for refractory glaucoma.
                154 cases (159 eyes) with refractory glaucoma underwent Hunan aqueous drainage (HAD) implantation from July 1995 to July 2001. Sixty-five eyes were combined with MMC (0.4 mg/ml, 1 to 5 mins). With success defined as the introcular pressure (IOP) greater than 6 mmHg but no greater than 21 mmHg at the last visit.
                The mean period of postoperative follow-up was 54.6 (range, 12-72) months. The IOP was lowered from preoperative (46.8 +/- 14.5) mmHg to postoperative (16.8 +/- 11.3) mmHg at the 1st year after surgery. The success rate with MMC and without MMC were 90.0%, 77.3% (P < 0.05) at the 1st year, 87.1%, 67.3% (P < 0.05) at the 2nd year, 83.3%, 61.1% (P < 0.05) at the 3rd year, 81.3%, 56.7% (P < 0.05) at the 4th year, and 75.0%, 50.0% (P < 0.05) at the 5th year using Kaplan-Meier life-table analysis. The height of the posterior bleb underwent standardized ocular echography at the 1st year was (3.8 +/- 0.9) mm and (2.1 +/- 1.4) mm, respectively. Ninty-five eyes (81.9%) with visual acuity remained or improved after the surgery (P > 0.05). The most frequent complications for long-term follow-up included elevated IOP (IOP > 22 mmHg) (19.8%), the iris adherent to the proximal orifice of the tube (15.5%), developed cataract formation (12.9%) and so on (P > 0.05). We didn't find any severe complications after using MMC.
                This study suggests that HAD implantation is an effective method in the management of refractory glaucoma in spite of its unneligible complications and combined with MMC can improve the prognosis.