Clinical Findings and Ocular Symptoms Over 1 Year in a Sample of Scleral Lens Wearers.

PURPOSE To report the fitting aspects, clinical findings, and symptoms over 12 months of scleral lens (SL) wear. METHODS Sixty-nine patients with irregular cornea due to ectasia or surgical procedures (IC group) or regular corneas with high ametropia (RC group) completed the 12-month prospective follow-up period. Patients were evaluated at baseline, lens dispensing visit, 1 month, 3 months, 6 months, and 12 months for assessment of comfort, fitting aspects, and slitlamp findings. Comfort was assessed with the Ocular Surface Disease Index (OSDI) questionnaire and Dry Eye Questionnaire. Slitlamp evaluations comprised on-eye lens fitting (lens alignment and tear reservoir thickness) and anterior ocular surface health after removing the lens (edema, hyperemia, staining, and adverse events). RESULTS OSDI Scores were significantly reduced after 1 month of SL wear comparing to baseline (from 47.0±22.7-23.9±14.7 in IC group, P<0.001 and 27.0±16.1-17.0±13.7, P=0.029 in RC group, P<0.05), without statistical significant differences from 1 to 12 months. Tear reservoir thickness showed a significant reduction at V1m (122 μm on IC group and 126 μm in RC group, P<0.05), that continued over time until V12m (195 and 184 μm lower compared with Baseline (P<0.05, Wilcoxon). Hyperemia and staining were significantly higher after SL removal when compared with baseline (P<0.05), and maintained the same behavior over the 12 months. There were no severe adverse events during the entire follow-up period. CONCLUSIONS Comfort enhancement promoted by SL remained over the entire follow-up. Despite no severe adverse events recorded over the 12 months of follow-up, higher hyperemia and staining grades were found after SL removal when compared with no-lens condition.