Prosthetic replacement of the ocular surface ecosystem: impact at 5 years

BACKGROUND/AIMS: To determine the impact of prosthetic replacement of the ocular surface ecosystem (PROSE) treatment at 5 years. METHODS: Retrospective review of clinical, manufacturing and quality databases at the Boston Foundation for Sight. RESULTS: 121 patients who completed treatment and had 5-year follow-up data were identified from a cohort of patients (n=199) seen in consultation for PROSE treatment from January 2008 to June 2008. Mean age was 52 years, M:F=56:65. The primary indication for treatment was ocular surface disease (OSD) in 64 patients and distorted corneal surface in 57 patients. At 5 years, continued device wear was confirmed in 89/121 (73.6%) patients. Discontinuation of wear was confirmed in 32/121 (26.4%). There was an increased likelihood of continued device wear at 5 years in patients with distorted cornea (84%) compared with those with OSD (64%), (p=0.0121, χ(2)). National Eye Institute Visual Function Questionnaire (NEI VFQ-25) composite score increased for patients wearing PROSE devices at 6 months (Δ=+23 points, mean=82, p<0.001, two-tailed t test) with no significant decline among those still wearing a device at 5 years (Δ=−4 points, mean=78, p=0.22, two-tailed t test). At 5 years, those wearing (mean=78) had a higher NEI VFQ-25 than those not wearing (mean=70, p=0.029, two-tailed t test). CONCLUSIONS: PROSE treatment offers continued benefit, as defined by improved visual function and continued device wear at 5 years, in patients with complex corneal disease. Patients with distorted cornea have a higher rate of continued wear at 5 years than patients with OSD, although this is not true among all subgroups within OSD.