Abstract
Background: Scleral lenses (SLs) are recommended in DEWS II to treat dry eye (DE) patients that do not respond well to conventional therapies. This study aimed to evaluate the short-term (one month) efficacy and safety of SLs in the management of severe DE. Methods: This single-center prospective study enrolled 15 patients (22 eyes) who were diagnosed with severe DE. The Ocular Surface Disease Index (OSDI), the Chinese version of the 25-item National Eye Institute Visual Function Questionnaire (CHI-VFQ-25), and LogMAR best-corrected visual acuity (BCVA) were evaluated at baseline and one month following SL fitting. DE-related parameters were obtained and analyzed before and after one month of SL treatment, including tear-film breakup time (TBUT), corneal fluorescein staining (CFS), non-invasive breakup time (NIBUT), tear meniscus height (TMH), Schirmer I test (SIT), and meibomian gland (MG) dropout. Complications and adverse events were monitored. Results: OSDI scores (53.9 ± 28.1 vs. 10.4 (4.2-25), p = 0.0001) and CFS scores (10.2 ± 3.9 vs. 7 (0-12), p = 0.001) decreased after one month of SL therapy, while CHI-VFQ-25 scores (74.4 (54.8-83.8) vs. 95 (78.7-98), p = 0.0001) and TBUT (0.6 ± 0.5 vs. 2.2 ± 1.0, p < 0.0001) increased significantly. LogMAR BCVA improved from 0 (0-0.1) to 0 (0-0) (p = 0.0147). The average types of medications per eye decreased from 2.82 ± 1.01 to 1.32 ± 0.64 (p = 0.025), and the proportion of eyes using glucocorticoids significantly decreased from 63.6% to 13.6% (p = 0.001). No severe SL-related adverse events were reported. Conclusions: SL treatment quickly alleviated subjective symptoms as well as clinical signs of DE with good safety and enhanced the visual function and vision-related quality of life, showing its usefulness in the management of severe DE.