Journal of refractive surgery (Thorofare, N.J. : 1995) · 2026
Corneal Allograft for Near Vision Improvement in Emmetropic Presbyopia: 4-Year Safety and Efficacy Results From a Prospective European Multicenter Clinical Trial.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Kilic Aylin, Cummings Arthur, Stodulka Pavel, Daya Sheraz, Hamada Samer, Gobbe Marine, Muller David, Mrochen Michael
Аннотация
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.
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.