About Refractec Employment Contact Us Patient Professsional Enter Zip Code:   Text Size Presbyopic Indications Approval of the premarket approval application supplement for the Refractec ViewPoint® CK System is for the temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of 1.00 D to 2.25 D, in patients 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of < 0.50 D in spherical and cylindrical components of the manifest refraction, and with ≤ 0.75 D of cycloplegic refractive cylinder and with a successful preoperative trial of monovision or history of monovision wear (i.e., dominant eye corrected for distance vision and non-dominant eye corrected for near vision). CK is an elective procedure with the alternatives including, but not limited to, reading glasses, bifocal eyeglasses, multifocal contact lenses, monovision contact lens wear, or other refractive surgeries. Approval of this application is based on a clinical trial of 150 patients treated for near vision in their non-dominant eye, with the other eye treated for distance vision in 38 of the patients. Of all eyes, 148 near vision treatments were available for analysis at 3 months, 146 eyes were available for analysis at 6 months, 94 eyes were available for analysis at 9 months, and 77 eyes were available for analysis at 12 months. Accountability was 99% at 3 months, 97% at 6 months, 97% at 9 months, and 96% at 12 months. The data analysis was based on the refractive data at all follow-up examination time points (1 month, 3, 6, 9, and 12 months). At 6 months, this analysis showed that 83% (67/81) eyes were corrected to (J3) 20/40 and 23% (19/81) were corrected to (J1+) 20/20 or better visual acuity without spectacles or contact lenses. The study showed that all the adverse events occurred at low rates (< 1%). Long-term risks of CK for improvement of near vision have not been determined. The safety and effectiveness of re-treatment procedures with the Refractec ViewPoint CK System or other refractive surgical devices have not been established. Hyperopic Indications The Refractec ViewPoint CK System is for the temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cycloplegic spherical hyperopia, less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), and a cycloplegic spherical equivalent of +0.75 D to +3.00 D. Patients must be 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of less than 0.50 D in spherical and cylindrical components of manifest refraction. The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction. CK is an elective procedure with the alternatives including, but not limited to, eyeglasses, contact lenses, photorefractive keratotomy (PRK), laser in situ keratomileusis (LASIK), or laser thermal keratoplasty (LTK). Approval of this application is based on a clinical trial of 401 eyes (233 primary and 168 secondary). Of all eyes treated, 358 eyes were available for analysis at 3 months, 352 eyes were available for analysis at 6 months, 350 eyes were available for analysis at 9 months, and 344 eyes were available for analysis at 12 months. Accountability was 99% at 3 months, 97% at 6 months, 96% at 9 months, and 99% at 12 months. The data analysis was based on the refractive at all follow-up examination time points (1 month, 3, 6, 9, and 12 months). At 12 months, this analysis showed that 318/344 (92%) eyes were corrected to 20/40 or better and 191/344 (56%) were corrected to 20/20 or better visual acuity without spectacles or contact lenses. The study showed that all adverse events occurred at low rates (<1%). Long-term risks of CK for hyperopia have not been determined. The safety and effectiveness of re-treatment procedures with the Refractec ViewPoint CK System or other refractive surgical devices have not been established. E-mail this Page   |   Print this Page   |   Indications for Use   |   Site Map   |   Contact Us Part #L-225-018 Rev. L ©2002-2009 Refractec, Inc., All rights reserved.