PURPOSE: To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy.
PATIENTS AND METHODS: Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%.
RESULTS: Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups.
CONCLUSIONS: There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology.
PURPOSE:: To compare the rate of visual recovery after Ex-PRESS implantation versus standard trabeculectomy.
PATIENTS AND METHODS:: Subjects enrolled in a prospective randomized controlled trial comparing Ex-PRESS to trabeculectomy were analyzed for postoperative changes in visual acuity (VA). Risk factors for visual loss (split fixation, cup-disc ratio, intraocular pressure, visual field mean deviation, and hypotony) were evaluated.
RESULTS:: Sixty-four subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). There was no significant difference in mean logMAR VA between groups at baseline or any study visit. VA was significantly reduced up to week 2 following surgery in both the groups. However, by month 1, VA in the Ex-PRESS group was no longer significantly different from baseline (P=0.23) and remained nonsignificant at subsequent visits up to 6 months. In the trabeculectomy group, VA remained significantly lower than baseline at each study visit. At 6 months, 47% of the trabeculectomy eyes compared with 16% of the Ex-PRESS eyes had lost ≥2 Snellen lines (P=0.01). Reasons for VA loss included cataract, central retinal vein occlusion, and diabetic retinopathy, however, in a significant number of cases no cause could be determined. None of the risk factors evaluated were associated with vision loss.
CONCLUSIONS:: Although there was no difference in mean VA between the Ex-PRESS and trabeculectomy groups at any time point, trabeculectomy eyes were more likely to lose ≥2 Snellen lines. In addition, VA recovered faster in the Ex-PRESS group.
PURPOSE: To evaluate the intraocular pressure (IOP)-lowering effect of trabeculectomy with the use of amniotic membrane transplant (AMT) compared with the standard trabeculectomy with Mitomycin-C (MMC) in patients with primary open-angle glaucoma.
PATIENTS AND METHODS: This study was a patient-masked, randomized, controlled comparison trial involving 52 eyes of 52 patients with bilateral primary open-angle glaucoma. Patients were randomized to receive trabeculectomy with AMT or trabeculectomy with MMC. The main outcome for comparison was the IOP-lowering effect of both procedures. Surgical success was considered if the patient's IOP was <22 mm Hg, and the IOPs were lowered by >20% without the use of any medication.
RESULTS: All surgeries passed uneventfully without intraoperative complications, and all patients showed significantly (P<0.05) lower IOP on the first postoperative day compared with their respective preoperative IOP with nonsignificant (P>0.05) difference between both study groups. All patients, irrespective of the operative procedure maintained significantly (P<0.05) lower IOP compared with their respective preoperative IOP till the end of 24 months follow-up. Moreover, patients of the AMT group showed lower IOP compared with those included in the MMC group throughout the follow-up period; however, the difference was not statistically significant at any point of the study period.
CONCLUSIONS: AMT exhibits potential as an alternative to MMC in trabeculectomy surgery. Over 24 months of follow-up, the use of AMT with trabeculectomy was safe and effective with an IOP-lowering effect comparable to that achieved with the use of MMC, and a reduced rate of postoperative complication.
PURPOSE: To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy.
DESIGN: Randomized, prospective, multicenter trial.
METHODS: A total of 120 eyes in 120 subjects were analyzed, including 59 eyes treated with EX-PRESS and 61 eyes treated with trabeculectomy. Both the EX-PRESS and the trabeculectomy groups were treated intraoperatively with mitomycin C and followed postoperatively for 2 years. Surgical success was defined as 5 mm Hg ≤ intraocular pressure ≤ 18 mm Hg, with or without medications, without further glaucoma surgery.
RESULTS: Mean intraocular pressure was significantly reduced compared with baseline in both groups (P < 0.001). Average intraocular pressure and number of medications were similar in both groups during follow-up, with mean intraocular pressure at 2 years after surgery of 14.7 ± 4.6 mm Hg and 14.6 ± 7.1 mm Hg in the EX-PRESS and trabeculectomy groups, respectively (P = 0.927). At 2 years after surgery, the success rate was 83% and 79% in the EX-PRESS and trabeculectomy groups, respectively (P = 0.563). Although visual acuity (logMAR) was significantly decreased on day 1 in both groups, the vision was not significantly different compared with baseline at 1 month after EX-PRESS implant (P = 0.285) and 3 months after trabeculectomy (P = 0.255). The variance of early postoperative intraocular pressure values was similar between groups on the first postoperative day but higher after trabeculectomy compared with EX-PRESS implant on day 7 (P = 0.003). The total number of postoperative complications was higher after trabeculectomy than after EX-PRESS implantation (P = 0.013).
CONCLUSIONS: Mean intraocular pressures, medication use, and surgical success were similar at 2 years after treatment with the EX-PRESS device and trabeculectomy. Vision recovery between groups was also similar throughout the study, although return to baseline vision was more rapid in the EX-PRESS group. Intraocular pressure variation was lower during the early postoperative period, and postoperative complications were less common after EX-PRESS implantation compared with trabeculectomy.
PURPOSE: To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial.
METHODS: In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied.
RESULTS: Mean preoperative intraocular pressure (IOP) levels (OLO: 28.0 ± 9.4; MMC: 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO: 3.4 ± 1.6; MMC: 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01).
CONCLUSIONS: With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group.
PURPOSE: Ex-PRESS shunt is an alternative filtration procedure to trabeculectomy. This study aimed to compare the 1-year cost differences between the 2 operations.
METHODS: Subjects were enrolled in a randomized controlled trial comparing Ex-PRESS to trabeculectomy. Surgical cost difference and 1-year postoperative costs (follow-up visits, additional procedures, and medications) were determined and compared. The 95% confidence interval of incremental cost-effectiveness ratio was estimated using bootstrap method.
RESULTS: Forty-three subjects with 1-year follow-up were included. Success rate was not significantly different for Ex-PRESS (65%) versus trabeculectomy (55%, P=0.49). Ex-PRESS had a net surgical cost of $956 greater than trabeculectomy. There was no significant difference in the overall postoperative cost [median (interquartile range); $485 (337, 822) vs. $609 (387, 820), P=0.78], cost of follow-up visits [$303 (275, 358) vs. $317 (275, 385), P=0.75], additional procedures [$182 (0, 365) vs. $182 (0, 365), P=0.69], or glaucoma medication [$0 (0, 68) vs. $0 (0, 90), P=0.8] for Ex-PRESS versus trabeculectomy, respectively. The overall 1-year cost was significantly greater for Ex-PRESS and the incremental cost-effectiveness ratio was $9625 (95% confidence interval, $2435-548,084).
CONCLUSIONS: Ex-PRESS is associated with greater surgical cost compared with trabeculectomy. This needs to be considered in conjunction with efficacy and safety if Ex-PRESS is to supersede trabeculectomy.
PURPOSE: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC).
MATERIALS AND METHODS: In a prospective, randomized, pilot study, 39 eyes of 33 subjects with medically uncontrolled primary glaucoma, aged 18 years or above underwent trabeculectomy either with MMC (20 eyes) or with Ologen implant (19 eyes). The primary outcome measure was cumulative success probability, defined as complete if the intraocular pressure (IOP) was > 5 and ≤ 21 mm Hg without anti-glaucoma medications or additional surgery and qualified if an IOP was > 5 and ≤ 21 mm Hg with or without anti-glaucoma medications.
RESULTS: Mean (± standard deviation) follow-up in Ologen group was 19.1 ± 8.1 months, and in MMC group was 18.0 ± 8.4 months. Mean IOP reduction at 6 months was significantly lower (P = 0.01) in the MMC group (11.9 ± 2.9 mm Hg) as compared to Ologen group (14.6 ± 2.7 mm Hg). However, at 12 months (P = 0.81) and 24 months (P = 0.32), the mean IOP was similar between the 2 groups. Complete success probability at the end of 6 months in Ologen group was 100% (95% confidence interval: 59.1 - 99.0) was similar (P = 0.53) to that in MMC group (93.8%, 95% CI: 63.2 - 99.1). The incidences of early post-operative complications were similar in the 2 groups, except hyphema, which was significantly more in Ologen group (P = 0.02).
CONCLUSION: In this pilot study, the success of trabeculectomy and complications were similar in both Ologen and MMC groups at the end of 6 months.
PURPOSE: To compare the results of subscleral trabeculectomy (SST) augmented with mitomycin-C (MMC) versus Ologen™ implant regarding intraocular pressure (IOP) control and incidence of complications.
METHODS: Sixty eyes of 60 patients, who planned to undergo SST, were divided into 2 groups. Group I eyes (included thirty eyes) were operated upon with SST augmented with intraoperative MMC. Group II eyes (included 30 eyes) were operated upon with SST using an Ologen implant. IOP and bleb status, as well as reporting postoperative complications, were followed up.
RESULTS: The follow-up period was 12 months. At 12 months postoperatively, the mean IOP was 19.33±3.22 mmHg in group I, and 19.87±4.17 mmHg in group II, with no significant difference between groups. One case in each group had hyphema, and 4 cases in group I and 2 cases in group II had shallow anterior chamber. One case in group I and no cases in group II had blebitis. There was no significant difference regarding the complications between both groups.
CONCLUSION: We conclude that the use of the Ologen implant in SST is comparable to the use of MMC with advantage of avoiding the potential dangerous complications related to MMC use in the early (12 months) follow-up period.
AIM: To observe effects of trabeculectomy with amniotic membrane transplantation (AMT) in controlling postoperative intraocular pressure (IOP) in patients with medically uncontrolled glaucoma.
METHODS: This study included adult patients with requiring bilateral glaucoma surgery. Each patient underwent trabeculectomy (Non-AMT group) in one eye and with AMT (AMT group) in the other eye according to randomized principle. Success was defined as intraocular pressure (IOP)<21mmHg without any anti-glaucoma medications at 24 months follow-up. The two groups were compared in terms of IOP, complications and success rate.
RESULTS: Thirty-four eyes of 17 patients were investigated in this study. There was no statistically signifcant difference in pre-operative IOP between the two groups. The mean IOP was lower in AMT group compared with Non-AMT group on follow up months 12, 18, and 24.Postoperative complications were more frequent in Non-AMT group (35.3%, 6/17) compared with AMT group (5.9%, 1/17). The success rate of surgery was 88.2% (15/17) in Non-AMT group and 100% (17/17) in AMT group.
CONCLUSION: Trabeculectomy with AMT is an effective procedure to reduce IOP and complications, thereby improving surgical success rates.
To compare the efficacy and safety of the Ex-PRESS glaucoma shunt with standard trabeculectomy.
PATIENTS AND METHODS:
Consenting patients with medically uncontrolled open-angle glaucoma were prospectively randomized to trabeculectomy or Ex-PRESS shunt both with mitomycin-C. Exclusion criteria included previous ocular surgery with the exception of clear cornea phaco or 1 previous trabeculectomy, uveitis, and vitreous in the anterior chamber. Standardized data collection sheets were completed at baseline and postoperative day 1, weeks 1 and 2, and months 1, 2, 3, 6, and 12. Primary outcome was intraocular pressure (IOP). Complete success was defined as an IOP between 5 and 18 mm Hg and a 20% reduction from baseline without medication. A sample size calculation determined that 52 eyes were required to detect a 2.0 mm Hg IOP difference with a power of 80%.
RESULTS:
Sixty-four subjects were enrolled, 33 in the Ex-PRESS and 31 in the trabeculectomy group. IOP was not statistically significantly different between groups. Baseline and 1-year mean IOP was 22.0±6.8 versus 22.7±10.3 mm Hg (P=0.76) and 11.6±4.5 versus 11.3±4.5 mm Hg (P=0.81) in the trabeculectomy versus Ex-PRESS groups, respectively. Complete success was 57% versus 70% (P=0.28) in the trabeculectomy versus Ex-PRESS groups, respectively. There were no statistically significant differences in surgical time, number of glaucoma medications, visual acuity, central corneal thickness, endothelial cell counts, complications, interventions, or bleb morphology between the trabeculectomy and the Ex-PRESS groups.
CONCLUSIONS:
There was no statistically significant difference between the trabeculectomy and Ex-PRESS groups regarding IOP, success rates, complications, additional interventions, and bleb morphology.
