Evaluation of the small-aperture intracorneal inlay: Three-year results from the cohort of the U.S. Food and Drug Administration clinical trial.

PURPOSE

To evaluate the safety and effectiveness of the Kamra small-aperture intracorneal inlay.

SETTING

Centers in North America, Europe, Asia, and Australia.

DESIGN

Prospective clinical trial.

METHODS

Patients with emmetropic presbyopia had intracorneal implantation of the inlay in the nondominant eye.

RESULTS

The study comprised 507 patients with emmetropic presbyopia who were aged 45 to 60 years old. The implanted eyes exhibited 3.5 diopters of defocus range above 20/40, with 363 (87.1%) of 417 patients and 391 (93.8%) of 417 patients having 20/40 or better monocular and binocular uncorrected near visual acuity (UNVA) at 36 months, respectively. Patients implanted via a femtosecond laser pocket procedure using a spot/line setting of 6 μm × 6 μm demonstrated further improved near vision, with 131 (90.3%) of 145 patients and 137 (94.5%) of 145 of patients having 20/40 or better monocular and binocular UNVA, respectively. Uncorrected distance visual acuity 20/25 or better was maintained in 135 (93.1%) of 145 of implanted eyes and 100% (145) of 145 of implanted eyes binocularly at 36 months. Less than 1.5% of eyes had a loss of 2 or more lines of corrected distance visual acuity for 3 months or more at any time after surgery. Forty-four inlays (8.7%) were removed from the full cohort over 3 years. The removal rate was significantly less in the 6 × 6 pocket group (3.0% for visual complaints) and further reduced with deeper implantation (0%). Less than 1.0% of the patients reported severe glare or halos postoperatively.

CONCLUSION

The small-aperture corneal inlay was found to be safe and effective, improving near vision both monocularly and binocularly with minimal effect on distance visual acuity.