Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) for Visual Rehabilitation in Limbal Stem Cell Deficiency.

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.

PROSE Treatment for Ocular Chronic Graft-Versus-Host Disease as a Clinical Network Expands.

BACKGROUND: Keratoconjunctivitis sicca occurs in 40% to 90% of patients with ocular chronic graft-versus-host disease (cGVHD). Ocular symptoms can have profound effects in both the visual function and quality of life of patients with GVHD. We report the impact of prosthetic replacement of the ocular surface ecosystem (PROSE) treatment in patients with cGVHD as a clinical network expands. METHODS: We queried the BostonSight PROSE manufacturing database from January 2002 to December 2011. Patients treated for ocular cGVHD were reported by age, gender, year, and network site where the treatment was undertaken. The baseline and six-month follow-up scores of visual function using a standardized validated instrument, the National Eye Institute Visual Function Questionnaire (NEI VFQ-25), were evaluated for a period in 2006 and again in 2010 after network expansion had occurred. RESULTS: A total of 407 patients with a male:female ratio of 226:181, mean age was 51 years with ocular cGVHD underwent PROSE treatment from January 2002 to December 2011. By 2011, 67% of all cases were treated at network clinics. Baseline characteristics of patients treated throughout the network in 2010 were similar to that of 2006 and 2010 cohorts from the main center. There was a significant improvement of 41 points (P<0.001) in composite NEI VFQ score among patients treated across the network in 2010, similar to the improvement of 30 points (P<0.001) seen among the patients treated at the main center in 2010. There was a trend toward lower baseline self-reported general health status (SRGHS) and VFQ scores among patients treated at network clinics, suggesting that expansion of the network allows treatment of sicker patients (lower general health status) or those more severely affected by ocular cGVHD. CONCLUSIONS: PROSE treatment of ocular cGVHD has increased in the last decade with the establishment of BostonSight network clinics across the United States. Patients treated at network clinics showed similar levels of baseline visual function and SRGHS, and achieved a similar high level of improvement in visual function as those treated at the main center. Patient-reported measures of functional status are useful in evaluating treatment options for patients with cGVHD. PROSE treatment has significant positive impact on the visual function of patients with ocular cGVHD regardless of whether the patient is treated at the main center or at a network site.

Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) scleral device compared to keratoplasty for the treatment of corneal ectasia.

PURPOSE: To compare the ocular characteristics and visual outcomes of eyes with corneal ectasia that were fitted with the Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) scleral device to those that underwent keratoplasty. DESIGN: Retrospective, comparative case series. METHODS: We reviewed the charts of consecutive patients with corneal ectasia that were evaluated for PROSE or underwent keratoplasty at our institution. Clinical data, topographic indices, and corneal thickness were reviewed, and eyes were stratified according to the Amsler-Krumeich classification for severity of ectasia. Only the more severe eye of each patient was included in the study. We compared visual acuity before and after PROSE fitting or keratoplasty. For PROSE evaluations, achievement of satisfactory fit and continued wear at 1 year of follow-up were recorded. RESULTS: From 2010 to 2012, 36 patients underwent PROSE evaluation for corneal ectasia while 37 patients underwent keratoplasty for the same indication. All eyes were successfully fitted with the PROSE device. Eyes in the keratoplasty group had more severe ectasia than eyes in the PROSE group (P = .038). Visual acuity was achieved more rapidly in the PROSE cohort compared to keratoplasty, and mean visual acuity was significantly better for all eyes (P < .0001) and when including only eyes with stage 4 ectasia (P < .001). More eyes with stage 4 ectasia achieved 20/25 visual acuity after PROSE than after keratoplasty (P = .003). At 1 year follow-up in the PROSE cohort, Snellen acuity was 20/28 (P = .108 vs keratoplasty), improving to 20/25 with over-refraction (P = .006 vs keratoplasty). CONCLUSIONS: Eyes with advanced corneal ectasia can be successfully fitted with the PROSE device, and the visual acuity outcome for stage 4 ectasia was better and more rapid compared to keratoplasty. The acuity remained excellent with 1 year of follow-up. PROSE evaluation should be considered in patients with advanced corneal ectasia before proceeding to keratoplasty, especially if the ectasia is deemed stable.

Current silicone hydrogel UVR blocking lenses and their associated protection factors.

PURPOSE: Ultraviolet radiation (UVR) blocking contact lenses provides ocular protection factors (PF) that vary with lens thickness and the nature of the polymer dopant. This study measured the UVR PF of silicone hydrogel lenses outdoors and compares this to known methods for determining PF mathematically. METHODS: Ambient measurements were taken using an UVA-B radiometer, adapted to hold the test lenses over its sensor to quantify their UVR blocking capabilities. The UVR blocking silicone hydrogel lenses tested included galyfilcon A, senofilcon A, and enfilcon A. The first UVR blocking hydrogel lens, vasurfilcon A, and a non-blocking silicone hydrogel lens, lotrafilcon B, served as a comparison. Lens transmittance at the centre and periphery was measured and PF calculated to predict signal reduction for comparison with field measurements. RESULTS: There was a significant range of cut-off wavelengths across the lenses, ranging from 370nm for enfilcon A to 390nm for vasurfilcon A, with lotrafilcon B transmitting down to 265nm, with a 3nm shift from centre to periphery across the -3.00 D UVR blockers. The UVR reduction calculated from the transmittance data correlates well with field data, ranging from 90-98% for the UVR blockers to 13% for the non-blocker. CONCLUSIONS: The silicone hydrogel lenses showed a wide range of transmittance curves with increasing PF from centre to periphery. PF calculations work well but do not always compare precisely with measured data due to factors such as sensor spectral response and the nature of the incident solar spectrum.