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June 1994

Randomized Clinical Trials on Medical Treatment of Glaucoma: Are They Appropriate to Guide Clinical Practice?

Author Affiliations

Blue Bell, Pa

Arch Ophthalmol. 1994;112(6):726-727. doi:10.1001/archopht.1994.01090180024003

The interesting article by Rossetti et al1 in the January 1993 issue of the Archives raises an old question: Can placebo-controlled studies be ethically justified when dealing with a potentially blinding disease? The authors adopt a tone that is critical of the substantial research that has been carried out in the management of glaucoma by lowering intraocular pressure; however, they show little appreciation of the three long-standing issues that researchers face in this area.2-4 First, in the presence of visual field loss or optic nerve changes, the relationship between elevated intraocular pressure and the extent of glaucomatous damage at the moment of diagnosis is well established. Second, apart from gross changes in the optic nerve head and visual field (on which there would be little disagreement), there are no universally accepted and validated end points for lesser stages of glaucomatous damage. Third, in many patients, especially those receiving

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