To evaluate the effectiveness and safety of a four-zone scleral lens design for visual rehabilitation in Chinese patients with irregular corneas.
Approach:
Study Design: A prospective, multi-center clinical trial involving 138 adults aged 18–65 years with irregular corneas across five Chinese centers.
Participants: Patients had irregular corneas due to keratoconus, secondary ectasia, corneal transplantation, or corneal scarring.
Follow-up: Participants were fitted with scleral lenses and followed for three months, with data collected from 201 treated eyes.
Key Findings:
97.7% of participants achieved successful visual rehabilitation at one month, defined as an improvement of at least 0.20 logMAR compared with spectacle correction.
98.5% of treated eyes gained two or more lines of vision, with a median improvement of 0.30 logMAR.
Fitting efficiency was high, with an average of 1.5 lenses per eye needed for optimal fit.
By three months, nearly 75% of participants wore lenses for at least eight hours per day.
No serious adverse events were reported, and no cases of corneal infection or new corneal neovascularization occurred.
Limitations:
The three-month follow-up limits conclusions regarding long-term safety.
The absence of a comparator lens group prevents direct comparisons with other specialty lens modalities.
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