Prospective, Multicenter Trial Of A Small Aperture Corneal Inlay For Improving Near Vision In Presbyopes

Patrick Versace

Purpose: To assess the ability of the Kamra small aperture inlay to improve near vision in emmetropes with presbyopia.

Methods: Prospective, multicenter clinical trial of 507 eyes. The Kamra (AcuFocus) corneal inlay (AcuFocus, Irvine, CA) is implanted in the non-dominant eye. The inlay was placed in a corneal pocket. Measures include uncorrected distance and near visual acuity (UCDVA, UCNVA) and patient satisfaction.

Results: At 6 months postoperative, 97.1% of the inlay implanted eyes achieved 20/40 or better and 66.3% achieved 20/20 or better UCDVA. UCNVA of 20/40 or better was achieved by 83.0% and 67.3% were 20/32 or better. For the implanted eye, 82.1% were able to see 20/40 or better for both near and distance vision, 65.4% 20/32 or better, and 14.7% of eyes achieved 20/20 or better near and distance vision. Mean reports of subjective symptoms (eg halos, glare) was <2% for all categories. Performing near tasks such as reading a newspaper, viewing a computer screen or seeing numbers on a cell phone were evaluated using a 7 point scale (1=not at all easy/ 7=very easy). Improvement in ease of activity score for near tasks from preop to 6 months ranged from 2.4 ± 1.9 to 3.0 ± 1.9 points.

Conclusion: The Kamra small aperture corneal inlay was successful in achieving good UCNVA in the implanted eye without impacting UCDVA.