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.
Patients should be cautioned to limit the wearing schedule by their eye care practitioner regardless of how comfortable the lenses feel.
The safety and effectiveness of the Boston Orthokeratology (oprifocon A) shaping lenses have not been clinically studies in adolescent and pediatric subjects. 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.
Boston Orthokeratology (oprifocon A) shaping lenses are supplied non-sterile in an individual plastic case. The lens is shipped dry and must be cleaned and conditioned prior to use.
A total of 378 eyes (191 patients) were enrolled in the clinical study. There were twelve significant lens-related adverse events reported in ten subjects. Two eyes had bilateral grade 4 staining with significant decrease in vision to 20/80. One eye had grade 3 corneal staining secondary to a dislodged lens. One eye had significant corneal distortion with reduced vision to 20/200 and rippling on the cornea. Two eyes had bilateral iritis with trace cells and flare in both eyes. One eye had corneal infiltrates. Two eyes had abrasions (grade 3 staining). One eye had reduction of BSCVA to 20/50 secondary to a decentered lens. One eye had reduction of BSCVA to 20/60 due to central staining. One eye had reduction of BSCVA to 20/60 with no reason given.
All 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. The return to pre-treatment VA was not recorded for this subject, although the subject returned to soft contact lens wear and verbally reported that vision was normal. All adverse events resolved without further complications.
ATTENTION: Refer to the package insert for a complete listing of indications, warnings and precautions, clinical trial information, etc.
CAUTION: Federal (USA) law restricts this device to the sale by, or on the order of a licensed practitioner.