Changes in Visual Acuity and Dry Eye Parameters Following One Month of Scleral Lens Wear in Patients with Keratoconus: A Prospective Observational Study from Saudi Arabia

Abstract

Background/Objectives: To evaluate the immediate visual correction provided by scleral lens insertion and short-term changes in ocular surface parameters associated with one month of scleral lens wear in patients with keratoconus in Saudi Arabia. Methods: This prospective observational study included 18 participants with keratoconus (18 study eyes). Scleral lenses were fitted bilaterally, while one eye per participant was selected for ocular analysis; when both eyes were eligible, the eye with the higher Kmax was selected. Participants were instructed to wear ONEFIT MED® scleral lenses for at least 8 h per day for one month. Outcomes included logMAR visual acuity, Ocular Surface Disease Index (OSDI), Schirmer I test, and invasive tear break-up time (ITBUT). Paired-samples t-tests were used for paired comparisons. Results: All 18 participants completed follow-up. Mean logMAR visual acuity improved immediately after lens insertion from 0.723 ± 0.550 to 0.089 ± 0.126 at baseline and from 0.760 ± 0.544 to 0.099 ± 0.126 at one month (both p < 0.001). Mean OSDI decreased from 45.45 ± 20.31 to 24.84 ± 11.24 (p < 0.001). Schirmer I increased from 14.50 ± 7.23 to 16.89 ± 7.15 mm (p = 0.001), and ITBUT increased from 4.94 ± 2.04 to 5.97 ± 1.74 s (p = 0.010). No adverse events or complications were reported. Conclusions: Scleral lenses provided substantial immediate visual correction, while one month of regular wear was associated with reduced dry eye symptoms and modest changes in tear secretion and tear-film stability. Because this was an uncontrolled observational study, the ocular-surface findings should be interpreted as associations rather than causal effects.