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Speaker debunks value of ‘one eye’ trial of medication
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WAIKOLOA, Hawaii — The long-held belief that the “one eye” trial of medication is an efficient solution for assessing treatment efficacy for lowering IOP is not true, and the practice should be abandoned, according to a speaker here.
“The one eye trial does not work in any way, shape or form that is efficient enough for us,” Robert D. Fechtner, MD, told colleagues at Hawaiian Eye. “The one eye trial has been taught throughout my career and has been a standard and advocated. The theory behind the one eye trial is you measure the pressure in both eyes, you treat one eye for 4 weeks or so, and then you measure the pressure in both eyes. You look at the change in the treated eye against the change in the untreated eye, and that’s your therapeutic effect.”
Robert D. Fechtner
Since 2002, the American Academy of Ophthalmology has included use of a one eye drug trial in its Preferred Practice Pattern for primary open-angle glaucoma; however, in 2015, the AAO updated that guidance to say, “Though monocular trials have been recommended in the past ... recent studies have shown that such trials are not good predictors of long-term efficacy. A better way to assess IOP-lowering response is to compare the effect in one eye with multiple baseline measurements in the same eye.”
The monocular trial assumptions are that spontaneous IOP variation is symmetric, the diurnal curve is reproducible over time, medication has no crossover effect, both eyes respond similarly to the same medication and patients use their drops as prescribed, he said.
All of these assumptions can be refuted, according to Fechtner.
“If you do a one eye trial it should only be because one eye needs treatment,” he said. – by Patricia Nale, ELS
Reference:
Fechtner RD. The value of the one eye trial of medication. Presented at: Hawaiian Eye; Jan. 16-22, 2016; Waikoloa, Hawaii.
Disclosure: Fechtner reports he is a consultant for Alcon, Bausch + Lomb, Glaukos and ForSight Vision, and he receives research funding from Alcon, Allergan and Aerie.