William Stewart and the ISV-205 Study Group are to be congratulated on their innovative approach to preventing and perhaps treating steroid-induced glaucoma using topical diclofenac sodium.1 Could we seek a few clarifications?
What was the basis for selecting a sample size of 136 volunteers? What difference in intraocular pressure was predetermined to be clinically significant to arrive at this sample size?
The study quotes and uses the article by Bartlett et al2 to state that first-degree relatives of patients with primary open-angle glaucoma have a 70% chance of an exaggerated intraocular pressure elevation when given corticosteroids for 6 weeks. Perhaps this was the basis for determining the number of subjects.
The study cited had only 13 subjects to identify steroid responders in first-degree offspring of patients with primary open-angle glaucoma. The article quotes that 69% had intraocular pressure elevations of at least 5 mm Hg and could be classified as . . . [Full Text of this Article]
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