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Paflufocon B in reverse geometry design

1 December 1999


The practice of Orthokeratology has been around since the invention of contact lenses. As techniques in manufacturing contacts have evolved, so have the results obtainable in Orthokeratology. The newer "reverse geometry'' lenses have allowed practitioners to produce dramatic alterations in corneal curvature in a short period of time. This study was a prospective, multi-center, open-label, non-randomized study to determine the safety; efficacy and acceptability of a new reverse geometry lens design. Traditional orthokeratology lens designs have relied on spherical radii in the lens periphery to create the desired flattening effect. The study design incorporates a series of aspheric curves in the lens mid-periphery to permit better lens alignment with the aspheric peripheral cornea. All lenses will be manufactured in a FDA approved RGP lens material, Paflufocon B. The study will enroll 14 patients, all who are currently optometry students. Subjects must meet the eligibility as outlined in the investigational protocol. All patients will be fitted with the new lens design that is flatter centrally and steeper in the periphery. Scheduled follow-up examinations will be conducted at two weeks, one, two, and three months after dispensing. Additional visits will be conducted at eight, twenty-four, fortyeight, and seventy-two hours after the three-month visit to determine the half-life of the unaided visual acuity improvement. It is hypothesized that the lenses are safe and effective and accepted by the usual population to be treated, for the reduction of the magnitude of naturally occurring myopia with refractive astigmatism when used according to the protocol of the study.


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