One eye had reduction of BSCVA to 20/60 with no reason given.Īll eyes that showed acuity reductions were documented as returning to normal vision, except two eyes of one subject with severe corneal staining that showed ≥2 lines loss of BSCVA. One eye had reduction of BSCVA to 20/60 due to central staining. One eye had reduction of BSCVA to 20/50 secondary to a decentered lens. Two eyes had abrasions (grade 3 staining). Two eyes had bilateral iritis with trace cells and flare in both eyes. One eye had significant corneal distortion with reduced vision to 20/200 and rippling on the cornea. One eye had grade 3 corneal staining secondary to a dislodged lens. Two eyes had bilateral grade 4 staining with significant decrease in vision to 20/80. There were twelve significant lens-related adverse events reported in ten subjects. The lens is shipped dry and must be cleaned and conditioned prior to use.Ī total of 378 eyes (191 patients) were enrolled in the clinical study. The potential impact of these factors should be weighed against the patient’s need for refractive reduction therefore, the continuing ocular health of the patient, and lens performance on the eye should be carefully monitored by the prescribing eye care practitioner.īoston Orthokeratology (oprifocon A) shaping lenses are supplied non-sterile in an individual plastic case. ![]() The safety and effectiveness of the Boston Orthokeratology (oprifocon A) shaping lenses have not been clinically studies in adolescent and pediatric subjects. Patients should be cautioned to limit the wearing schedule by their eye care practitioner regardless of how comfortable the lenses feel. When selecting an appropriate lens design and parameters, the eye care practitioner should consider all factors that affect lens performance and the patient’s ocular health including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter. Although the safety risks of overnight wear with removal upon wakening may not be as great as with extended wear, there is still increased risk beginning with the first overnight period. Wearing the lenses continuously (extended wear) presents increased risk, which increases with the number of consecutive days the lenses are worn between removals. Orthokeratology lenses are to be worn overnight with removal during all or part of each following day. It is recommended that contact lens wearers see their eye care practitioners twice each year, or if directed, more frequently. Additionally, smoking increases the risk of ulcerative keratitis for contact lens wearers. This risk can be reduced by carefully following directions for routine lens care, including cleaning the storage case. The risk among extended wear use users increases the number of consecutive days that lenses are worn between removals, beginning with the first overnight use. ![]() The risk of ulcerative keratitis has been shown to be greater among wearers of extended wear lenses than among wearers of daily wear lenses.
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