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In Reply We agree with Bunce and Wormald that all important information regarding an individual’s participation in a trial including the option of enrolling 1 or both eyes and whether the eyes will receive different treatments if both are enrolled must be explained in the informed consent form and discussed with the individual. To our knowledge, in Diabetic Retinopathy Clinical Research Network trials, enrolling both eyes has not been an issue from the participant’s perspective. To Bunce and Wormald’s second point, we noted in our article that patient-level outcomes such as quality of life cannot be interpreted when one eye receives one treatment and the other eye receives another treatment.
Corresponding Author: Adam R. Glassman, MS, Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647 (email@example.com).
Published Online: August 20, 2015. doi:10.1001/jamaophthalmol.2015.2759.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Mr Glassman reported receiving a grant from the National Eye Institute. Ms Melia reported receiving a grant from the National Eye Institute and serving on the data and safety monitoring board for Alimera Sciences.
Glassman AR, Melia M. Considerations for Randomizing 1 Eye or 2 Eyes—Reply. JAMA Ophthalmol. 2015;133(10):1221. doi:10.1001/jamaophthalmol.2015.2759
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