Objectives: To evaluate the clinical outcomes of patients with limbal stem cell deficiency (LSCD) who were fitted with the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) scleral device.
Methods: In this retrospective, interventional case series, we reviewed the charts of 31 eyes of 19 consecutive patients clinically diagnosed with LSCD who were evaluated for the PROSE device. Clinical data were reviewed before PROSE evaluation and at the last available follow-up. The main outcomes measures were best-corrected distance visual acuity (CDVA) and modified ocular involvement score (OIS), graded using a previously described system for corneal findings.
Results: Corrected distance visual acuity improved from 0.86±0.50 logarithm of the minimal angle of resolution (Snellen equivalent, 20/145) at baseline to 0.46±0.44 (Snellen equivalent, 20/58) with PROSE at the last follow-up (mean, 25.1±18.0 months; P<0.0001). In 27 eyes (87.1%) CDVA improved, with 22 eyes (71.0%) gaining 2 or more lines of Snellen acuity. When categorized by disease severity, CDVA improved in less severe eyes (stage 1) and more severe eyes (stage 2 or 3; P=0.049 and P=0.00009, respectively). Total OIS was not significantly different between baseline and last follow-up (P=0.754); however the epithelial defect score was significantly less (P=0.034). Twenty-four of 31 eyes (77.4%) continued wearing the PROSE device, with a mean daily wearing time of 10.0±4.6 hrs.
Conclusions: In patients with LSCD, vision improved and the OIS remained stable with PROSE, suggesting that the device could be considered for visual rehabilitation in this population.