Corneal Allograft for Near Vision Improvement in Emmetropic Presbyopia: 4-Year Safety and Efficacy Results From a Prospective European Multicenter Clinical Trial.

PURPOSE: To evaluate both short- and long-term safety and effectiveness of intrastromal implantation of the corneal inlay for providing near vision in patients with presbyopia.

METHODS

This multicenter, prospective study included adults who had emmetropia (45 to 65 years old) with astigmatism of 0.75 diopters (D) or less and a near addition of 1.75 D or greater. After creation of a femtosecond laser flap, the sterile corneal inlay allograft was implanted on the stromal bed of the non-dominant eye and centered over the light-constricted pupil. Refraction and monocular and binocular visual acuity at distance, intermediate, and near were measured at the 6-month, 12-month, and 4-year visits.

RESULTS

A total of 101 patients were treated, with 94 available at 6 months and 71 at 4 years. At 6 months, mean binocular uncorrected distance (UDVA), intermediate (UIVA), and near (UNVA) visual acuity were -0.11 ± 0.07, 0.09 ± 0.18, and 0.03 ± 0.11 logarithm of the minimum angle of resolution, respectively. Binocularly, UDVA was 20/20 or better in 95.7% of patients at 6 months and 94.4% at 4 years; UNVA was 20/40 or better in 98.9% of patients at 6 months and 98.6% at 4 years compared to 16% preoperatively. Mean spherical equivalent was -0.69 ± 0.50 D at 6 months and -0.52 ± 0.64 D at 4 years, with no increased astigmatism. Monocular distance-corrected near visual acuity was 20/40 or better in 88.3% of treated eyes at 6 months and 78.9% at 4 years. At 6 months, all corneas were clear. The inlay was explanted in 3 eyes before 6 months due to anisometropia intolerance; all recovered without sequelae.

CONCLUSIONS

Implantation of a sterile allograft stromal inlay in the non-dominant eyes of patients with emmetropic presbyopia was safe and effective in improving near and intermediate vision while maintaining distance vision up to 4 years after surgery.