Prospective evaluation of a novel silicone corneal shield after PRK: 6-month efficacy, safety, and predictability outcomes

PURPOSE: The aim of this study was to report the 1-week and 6-month refractive outcomes of eyes treated with a novel silicone corneal shield designed to improve visual recovery after photorefractive keratectomy (PRK). PATIENTS AND METHODS: This prospective, observational clinical trial recruited 45 myopic eyes with or without astigmatism at a university eye clinic to undergo wavefront-guided PRK followed by application of an investigational silicone corneal shield that was removed on postoperative day 4. The primary outcome measures were efficacy, predictability, and safety at the 6-month visit. The secondary end points included short-term uncorrected distance visual acuity (UDVA) and pain. RESULTS: No adverse outcomes occurred using the device. At 6 months, 79.5% of eyes achieved UDVA >20/20, 94.9% achieved ≥20/25, and 97.4% achieved ≥20/40. Also, 2.6% lost one line of corrected distance visual acuity and none lost two lines; 71.8% and 97.4% measured within ±0.25 and ±0.50 D of emmetropia, respectively. During the first week, preoperative UDVA improved from 1.34 logarithm of the minimum angle of resolution (logMAR; <20/400 Snellen) to 0.14 logMAR (>20/30) on postoperative day 1 (P<0.0001) and remained stable on days 2–3 (all P>0.05). After removal of the shield on day 4, UDVA declined by two lines before rebounding to 0.16 logMAR (>20/30) on day 7 (both P<0.001). Subjective metrics of pain all peaked between days 2 and 3 before declining. CONCLUSION: The investigational silicone corneal shield is safe and effective when used after PRK and may aid early visual recovery and patient comfort, but comparative studies are needed to validate these preliminary findings. PRECIS: One-week and 6-month refractive outcomes of a novel silicone corneal shield used after PRK show that the device is not only safe and effective but may also speed visual recovery.