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July 29, 2026Clinical Trials

Design and monitoring of randomized trials in vision research with binary endpoints

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Authors

GDGuoqing DiaoQZQiang ZhangTHToshimitsu Hamasaki

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Overview

Randomized trial investigates a unified design for binary endpoints in vision research, indicating improved efficacy monitoring.

Key Points

  • This research aims to enhance the design and monitoring of randomized eye trials using binary endpoints by addressing existing gaps.
  • Proposed a unified design for binary endpoints in eye trials considering correlations between eyes.
  • Derived closed-form formulas for sample size and power calculations using a generalized linear mixed model.
  • Described interim monitoring strategies for determining efficacy and futility boundaries.
  • Simulation studies show that the proposed unified design outperforms existing individual designs for clustered binary data.
  • The methods demonstrate practical efficacy in various trial scenarios, including one-eye and two-eye designs.

Cite This Study

Diao et al. (2026) studied this question.

synapsesocial.com/papers/6a69a2e2c8da07d9defa6deahttps://doi.org/10.1177/17407745261468235
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