Purpose: To compare baseline characteristics and visual acuity outcomes in patients treated with prosthetic replacement of the ocular surface ecosystem (PROSE) versus other standard-of-care (SOC) treatments for postsurgical lagophthalmos and exposure keratopathy.
Methods: An institutional review board-approved, retrospective cohort study of 45 consecutive patients (53 eyes) with postsurgical lagophthalmos and exposure keratopathy following oculoplastic or skull base surgeries treated between August 2011 and August 2017 was performed. Patients treated with PROSE (22 patients, 27 eyes) were identified by referrals made to the PROSE treatment program at Weill Cornell Medical College. Patients treated with SOC treatments (23 patients, 26 eyes) were identified by International Classification of Diseases-9 and International Classification of Diseases-10 search of billing records. SOC treatments included ocular surface lubrication (artificial tears and/or punctal plugs), tape tarsorrhaphy and/or moisture chamber, or surgical correction. The primary outcome measure was best-corrected visual acuity converted to logMAR at baseline and at 1, 3, 6, and 12 months. Secondary outcome measures were subjective patient reports of improvement in vision and comfort, as well as presence of punctate epithelial erosions and/or corneal haze on slit-lamp examination before and after treatment.
Results: Average age for all patients was 52 ± 22 years (range: 7-87). Twenty-eight (62%) of total patients were male. Baseline corrected logMAR visual acuity was 0.58 ± 0.40 (20/76) for PROSE and 0.27 ± 0.39 (20/37) for SOC cohorts (p < 0.001). Mean number of failed prior treatments was 8.3 ± 3 for PROSE and 2.1 ± 2 for SOC (p < 0.0001). Mean difference in logMAR visual acuity for PROSE versus SOC, respectively, from baseline to 1 month was 0.33 ± 0.26 (3-line improvement) versus 0.01 ± 0.17 (no line improvement; p < 0.0001), to 3 months was 0.31 ± 0.23 (3-line improvement) versus 0.08 ± 0.30 (4-letter improvement; p = 0.0004), to 6 months was 0.31 ± 0.28 (3-line improvement) versus 0.10 ± 0.36 (1-line improvement; p = 0.02), and to 12 months was 0.32 ± 0.28 (3-line improvement) versus 0.12 ± 0.34 (1-line improvement; p = 0.01).
Conclusions: Patients with postsurgical lagophthalmos and exposure keratopathy treated with PROSE are more likely to have failed a higher number of treatments and have worse initial best-corrected visual acuities than those treated with SOC. Prosthetic replacement of the ocular surface ecosystem causes rapid and substantial visual improvement within 1 month of use compared with SOC, with little change beyond this time and sustained best-corrected visual acuity at 3, 6, and 12 months after treatment.