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.
RCT Entities:
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.