We thank Drs. Galvis, Tello, Parra, and Leiva for their interest and comments regarding our recent publication. We agree that an aggressive corneal wound healing response with a significant refractive shift is not a common outcome using an optimized surgical technique and the current version of the KAMRA inlay. As they have pointed out, such outliers were more commonly seen with earlier versions of the inlay implanted under thick flaps, sometimes combined with simultaneous LASIK using the same flap rather than a pocket or with suboptimal surgical protocols. Through extensive research, we have identified key variables that contribute to more activated wound healing and subsequent refractive change. For example, in the clinical trial (N = 508) surgical protocol, surgeons were allowed to use their preferred technique and laser settings. The KAMRA inlay was inserted into a lamellar pocket (93%) or under a flap (7%) at different depths (from 170 to 270 μm). Additionally, the method of lamellar resection (femtosecond laser or mechanical microkeratome), spot and line separation, and laser energy varied between investigational sites. The results from the clinical trial demonstrated that subjects implanted with the KAMRA inlay into a stromal pocket created using a femtosecond laser with ≤6 × 6 μm spot and line separation settings achieved significantly better uncorrected near visual acuity and refractive stability and reported a higher level of satisfaction with fewer removals. Over 95% of the subjects in the ≤6 × 6 pocket subgroup (n = 166) remained within ±1.00 diopter of manifest refractive spherical equivalent (MRSE) between 18–24, 24–30, and 30–36 months. Furthermore, among the ≤6 × 6 pocket subgroup, there was a trend toward better refractive stability with deeper stromal pockets (≥230 μm).

A spectrum of wound healing responses is not an unexpected postoperative reaction to keratorefractive procedures. In KAMRA inlay patients, the incidence and degree of corneal wound healing response can be minimized by using a femtosecond laser with ≤6 × 6 μm spot and line separation for creation of a smooth lamellar pocket and by implanting the inlay in a deeper pocket. The wound healing response can also be modulated by treating it with steroids. In the clinical trial, the treatment of subjects who experienced a wound healing response at 6 months was variable. Only 5% of subjects who experienced a wound healing response in the clinical trial had a recurrence of the response after treatment, and in such cases the best course of action would be surgical intervention such as enhancement or removal. The clinical trial data suggest that earlier removal leads to better recovery of best-corrected visual acuity (Fisher exact test, P < .0001).