Risk of Bias When Using Early Failure Criteria in Randomized Clinical Trials With Stereoacuity Outcomes.

Purpose: The purpose of this study was to explore the effects of early failure criteria for participants in randomized clinical trials (RCTs) on overall trial conclusions.

Method: We simulated 10,000 hypothetical RCTs with 2 treatments, 1 linear improvement and 1 with increasing rate of improvement and 6 follow-up visits. Each RCT had 400 participants, with the same baseline stereoacuity distribution.