Intrastromal corneal ring segments: Reversibility of refractive effect

PURPOSE: To evaluate the reversibility of refractive effect following remov al of the ICRS (intrastromal corneal ring segments; Intacs), METHODS: Data from 34 eyes from which ICRS were removed during United State s FDA Phase II and III clinical trials were evaluated with regard to segmen t size, loss or change of best spectacle-corrected visual acuity (BSCVA), a ny change of uncorrected visual acuity (UCVA), manifest spherical equivalen t refraction, manifest cylinder refraction, stability of manifest cylinder refraction, and subjective visual symptoms. RESULTS: Out of 725 initial or contralateral eyes placed with the ICRS duri ng Phase Ii and III clinical trials, segments were removed from 34 eyes (4. 7%). Other than one (1/725, 0.1%) safety related ICRS removal, 30/725 (4.1% ) were due to visual symptoms. ICRS removal was accomplished under topical anesthesia without complications in all eyes. The mean length of time the s egments remained in the cornea after initial surgery was 10.3 +/- 5.4 month s, At 3 months after ICRS removal, 21 eyes had monitored data available and were within +/-1 line or 10 letters of their preoperative BSCVA. Twenty ey es (20/21, 95%) returned to within +/-1.00 D of their preoperative manifest spherical equivalent refraction, All eyes had a stable refraction at the 3 -month examination after removal, and a manifest spherical equivalent refra ction within +/-1.00 D of their 1-month examination after removal. Nineteen eyes (19/21, 90%) returned to within +/-2 lines and 16 eyes (16/21, 76%) r eturned to within +/-1 line of preoperative UCVA CONCLUSION: The ICRS (Intacs) was easily and safely removed, and eyes retur ned to preoperative refractive status within 3 months.