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Session: Refractive Implantable Devices

"Expanded Ranges for Intacs(tm) Corneal Ring Segments"

Author: Bradley Fouraker, M.D.

USF Eye Institute

12901 Bruce B. Downs Blvd.

MDC 21

Tampa, FL 33612-4742

USA

Phone: 813-974-3820

Fax: 813-974-5621

Purpose: To evaluate safety and efficacy results of expanded Phase III trial for Intacs(tm).

Methods: 39 patients placed with 0.21 mm Intacs with spherical equivalent refractive errors between -0.50 and -1.00 D and 79 patients placed with 0.40 and 0.45 mm Intacs with spherical equivalent refractive errors between -3.00 and -4.50 D with </= 1.00 D cylinder each received the Intacs in one eye.

Results: Six month data on 25 eyes with the 0.21 mm Intacs showed excellent uncorrected visual acuities of 20/20 or better in 92% and 20/40 or better in 100% of patient eyes. Cycloplegic refraction SE showed 76% of subject eyes to be within +/- 1.00 D of the intended correction. Six month data on 72 eyes for the 0.40 and 0.45 mm Intacs for moderate myopia, showed significant improvement with uncorrected visual acuities of 20/20 or better in 64% and 20/40 or better in 94%. Cycloplegic refraction SE showed 57% of subject eyes to be within ± 0.50 D and 86% to be within ± 1.00 D of the intended correction. No patients lost more than 2 lines of BSCVA.

Conclusions: Intacs predictably decrease mild to moderate myopia and are well-tolerated. Updated information will be provided.

*KeraVision, Inc.