Abstract
Purpose:
To determine the impact at five years of Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) treatment.
Methods:
All patients seen in consultation for PROSE treatment from 1/1/2008 - 6/30/2008 were entered into a clinical data base. Retrospective review of this data base, medical records, and five year quality data was undertaken.
Results:
This 2008 cohort consisted of 199 patients, mean age 52 years (range 8-96), M:F = 96:103. Primary indication for treatment was ocular surface disease (OSD) in 112 patients and corneal ectasia/irregular astigmatism in 87 patients. 47 patients were classified as non-candidates at consultation or they did not complete the customization and training process. An additional 16 patients had died by conclusion of 5 year follow-up, July 2013, and were excluded from subsequent analysis. We report on the remaining 136 patients who were dispensed devices. At five years, continued device wear was confirmed in 89/136 (65%) patients. Discontinuation of wear was confirmed in 32/136 (24%) patients; the most common reasons for discontinuation are reported. We could not ascertain wearing status in the remaining 15 (11%) patients. There was an increased likelihood of continued device wear at five years in patients with corneal ectasia/irregular astigmatism (83%) compared to those with OSD (65%), (p=.0266, chi-square). A subgroup of patients with ocular surface disease, those with ocular chronic graft-versus host disease, had 5 year wearing rate (77%) equal to that of patients with ectasia/irregular astigmatism (p=0.6101). The NEI VFQ-25 composite score increased for patients wearing PROSE devices at 6 months (Δ = +22 points, p<0.001, mean=81) with no significant decline among those still wearing a device at five years (Δ = -3 points, p=0.27, mean =78). The correlates of success as measured by wearing status at 5 years and visual function at 6 months and 5 years using multifactorial regression analysis are reported.
Conclusions:
PROSE treatment offers continued benefit, as defined by improved visual function and continued device wear at five years, to two thirds of candidates with complex corneal disease. Patients with corneal ectasia/irregular astigmatism have a higher rate of continued wear at 5 years than patients with ocular surface disease, although this is not true among all sub-groups. Factors associated with long-term success or failure of PROSE treatment for complex corneal disease warrant continued investigation.
Keywords: 479 cornea: clinical science •
486 cornea: tears/tear film/dry eye •
574 keratoconus