Adjunctive @entity1138 or Amniotic Membrane Transplantation for Ahmed XXXX : A Randomized Clinical Trial.

@entity1 @entity101 @entity1138 @entity726 @entity1139
PURPOSE: To determine whether adjunctive @entity1138 ( @entity1139 ) or amniotic membrane transplantation (AMT) improve the outcomes of @entity726 valve (AGV) implantation. METHODS: This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 @entity1 aged 7 to 75 years with @entity726 . Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with @entity1139 (group B, 25 eyes), and AGV with AMT (group C, 25 eyes). RESULTS: The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 @entity1 including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the @entity1139 group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. @entity101 phase was slightly but insignificantly more common with standard surgery (82%) as compared with @entity1139 -augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28). CONCLUSIONS: Although adjunctive @entity1139 and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including @entity101 phase, were also comparable.
