The intrastromal corneal ring segments. Phase II results for the correction of myopia.

OBJECTIVE

The purpose of the study was to evaluate the safety and efficacy of the intrastromal corneal ring segments (ICRS) for the correction of myopia.

DESIGN

A 2-year phase II clinical trial of ICRS was initiated in May 1995. The investigational plan specifies that 150 patients with sighted eyes, requiring myopic corrections from -1.00 to -6.00 diopters (D), will each receive ICRS in 1 eye. The patient population will be divided into approximately five patients per ICRS thickness (0.25, 0.30, 0.35, 0.40, and 0.45 mm) per site. Six investigational sites are participating in the trial.

PARTICIPANTS

Fifty-nine men and 43 women requiring myopic corrections were enrolled at four U.S. investigational sites. These 102 patients each received the ICRS product in 1 eye.

INTERVENTION

Correction of myopia.

MAIN OUTCOME MEASURES

Efficacy of ICRS was assessed with respect to the trial endpoints of predictability of refractive effect, uncorrected visual acuity (UCVA), stability of UCVA, maintenance of best spectacle-corrected visual acuity and stability of refractive effect.

RESULTS

As shown by the available month-3 data (99 patients; all device thicknesses), 95 (96%) of 99 patients had a UCVA of 20/40 or better. Ninety-eight (99%) of 99 patients were within 2 lines of their preoperative best spectacle-corrected visual acuity. The average change (with standard error) in cycloplegic refraction (spherical equivalent) achieved by ICRS thickness was -1.27 +/- 0.09 D (0.25 mm), -2.13 +/- 0.16 D (0.30 mm), -2.56 +/- 0.15 D (0.35 mm), -3.77 +/- 0.37 D (0.40 mm) and -4.16 +/- 0.24 D (0.45 mm). Seventy-seven percent (76/99) of the patients were within +/-1.00 D of their intended correction. When the ICRS was removed in two cases, both patients returned to within 0.75 D of their preoperative manifest refraction.

CONCLUSIONS

The ICRS appears to be a viable and effective alternative for the treatment of myopia. Additionally, as indicated by the explant data, the ICRS's refractive effect may be reversible upon removal of the device.