Small-aperture corneal inlay for the correction of presbyopia: 3-year follow-up

Orang Seyeddain, M.D., Melchior Hohensinn, M.D., Wolfgang Riha, M.D., Gerhard Nix, M.D., Theresa Rückl, M.D., Günther Grabner, M.D., Alois K. Dexl, M.D., M.Sc.

J Cataract Refract Surg (January) 2012; 38:35–45

Purpose: To report the 3-year post-op safety and efficacy outcomes of the AcuFocus corneal inlay Setting: University Eye Clinic, Paracelsus Medical University, Salzburg, Austria Design: Prospective, non-randomized, non-comparative cohort study Methods: The corneal inlay was implanted in the non-dominant eye of naturally emmetropic presbyopic patients. Refraction, uncorrected near (UNVA), intermediate (UIVA), and distance (UDVA) visual acuities; corrected distance visual acuity (CDVA); contrast sensitivity; visual fields; subjective patient satisfaction and symptoms; and operative and post-operative adverse events and complications were evaluated.
Results: The study enrolled 32 patients. The mean UNVA improved from Jaeger (J) 6 pre-operatively to J1 at 3 years and the mean UIVA, from 20/40 to 20/25, respectively. At 3 years, 97% of eyes had a UNVA of J3 or better and 91% had a UIVA of 20/32 or better. The mean UDVA was 20/20, with all eyes achieving 20/32 or better. Nine eyes (28.3%) lost 1 line of CDVA, 1 eye (3.1%) lost more than 2 lines (3.8 lines), and 3 eyes (9.3%) gained 1 line. No inlay was explanted, and no inflammatory reactions were observed. At 3 years, 15.6% of patients reported severe night-vision problems and 6.3% (versus 87.5% pre- operatively) reported being dependent on reading glasses.
Conclusions: These 3-year results support the safety and efficacy of the corneal inlay to correct presbyopia in naturally emmetropic presbyopic patients. However, despite a significant gain in UNVA and UIVA, 28.3% of patients lost 1 line of CDVA.