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November 1989

Functional Blindness in Photorefractive Keratectomy-Reply

Author Affiliations

New Orleans, La

Arch Ophthalmol. 1989;107(11):1564-1565. doi:10.1001/archopht.1989.01070020641004

In Reply.  —We appreciate the concerns expressed by Drs Michaelson, Weinstein, and Nordan. We would like to state clearly that had we been certain that this patient's blindness was functional rather than physiological, we would have excluded her from the study. However, according to the guidelines established for the study, functional blindness is not a contraindication, and her inclusion is not in any way a violation of the protocol.In response to Dr Weinstein's question about the Food and Drug Administration procedure, we were permitted to use Dr Trokel's Investigational Device Exemption because he is also a collaborator in this study with VISX Inc, the developer of the excimer laser we are using. This privilege was extended to us, as collaborators, in a straightforward manner that is not unusual in multicenter collaborative research.Regarding the diagnosis of functional blindness, we agree with Dr Weinstein that, in the face of an

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