Ophthalmic Randomized Controlled Trials Reports: The Statement of the Hypothesis

The clinical objective commonly was stated, but the prospectively defined hypothesis tended to be understated in ophthalmic RCTs. Superiority was the most common type of comparison. Conclusions made in some of them with negative results were not consistent with the hypothesis, indicating that noninferiority or equivalence may be a more appropriate design. Flaws were common in the noninferiority and equivalence studies. Future ophthalmic researchers should choose the type of comparison carefully, specify the hypothesis clearly, and draw conclusions that are consistent with the hypothesis.