Removability of a small aperture intracorneal inlay for presbyopia correction

Purpose: To evaluate the safety of the corneal inlay removal procedure and the reversibility of visual acuities, corneal topography, and corneal biomicroscopy changes in a series of cases.

Methods: Ten cases implanted with one of three versions of the AcuFocus Kamra Inlay (ACI 7000, 7000T, and 7000PDT; AcuFocus, Inc., Irvine, CA) were followed for a minimum of 6 months after corneal inlay removal.

Results: The reason for removal was related to subjective dissatisfaction with visual symptoms (8 of 10 patients) such as night glare, photophobia, starburst, blurry vision, and halos. One case of removal was related to inadvertent thin flap and the final case was related to insufficient near vision. Mean uncorrected distance visual acuity (UDVA) and uncorrected near visual acuity (UNVA) was 0 ± 0.1 logMAR (Snellen 20/20) and 0.5 ± 0.2 logMAR (Snellen 20/40), respectively, preoperatively and 0.1 ± 0.1 logMAR (Snellen 20/25) and 0.5 ± 0.1 logMAR (Snellen 20/63), respectively, 6 months after corneal inlay removal. Mean corrected distance visual acuity (CDVA) and corrected near visual acuity (CNVA) was 0 ± 0.1 logMAR (Snellen 20/20) and 0 ± 0.1 logMAR (Snellen 20/20), respectively, preoperatively and 0 ± 0.1 logMAR (Snellen 20/20) and 0.1 ± 0.1 logMAR (Snellen 20/25), respectively, 6 months after corneal inlay removal. Mean root mean square (RMS) higher-order aberration (HOA) was 0.50 ± 0.12 (range: 0.30 to 0.70) preoperatively and 0.69 ± 0.14 (range: 0.48 to 0.95) 6 months after corneal inlay removal (P < .8). Weak positive correlation was found between Δt Implant-Removal (Δt I-R), RMS spherical, coma, and HOA at 6 months (Δt I-R vs RMS spherical was r = 0.2, r(2) = 0.5, P < .7; Δt I-R vs RMS coma was r = 0.8, r(2) = 0.6, P < .3; and Δt I-R vs HOA r = 0.8; r(2) = 0.6, P < .9).

Conclusion: This study suggests that after removal of the corneal inlay, corneal topography and corneal aberrometry are not permanently affected. In more than 60% of patients, CNVA, CDVA, UNVA, and UDVA were similar to the preoperative value.