PURPOSE:

The Zenlens custom scleral lens (SL) incorporates design flexibility and extensive customizable parameters to enable a precise, custom fit in individuals with a range of ocular conditions and corneal irregularities. Among the available customizations, MicroVault technology allows the lens to precisely vault over a peripheral obstruction. This retrospective multi-country case review aimed to gain insight into real-world visual outcomes and lens fitting practices with Zenlens. This sub-analysis focused on customization with MicroVault.

METHODS:

Ten eye care practitioners (ECPs) from three countries provided a deidentified retrospective convenience sample of ≥5 cases each using a standardized case report form (CRF), including ≥3 complex cases with a range of customizations. Data collected included best-corrected visual acuity (BCVA), comfortable wearing time, lens fitting patterns, and number of modifications required to achieve a successful fit. The protocol received central institutional review board exemption. Descriptive statistics are reported.

RESULTS:

The full analysis set included all submitted CRFs from 10 ECPs (62 eyes; 45 patients). This sub-analysis included CRFs from 7 ECPs utilizing MicroVault technology: 10 patients (7 female, 3 male; mean±SE age 50±5 years) and 11 eyes (OD, 5 patients; OS, 4 patients; OU, 1 patient). The most common diagnosis was keratoconus (5/11 eyes); other reasons for SL utilization included high or irregular astigmatism. Reasons for MicroVault utilization included ocular trauma and scarring, and a post-surgical bleb. Results are reported for all eyes/patients, unless otherwise stated. Prior to SL fit, a best-spectacle-corrected visual acuity of 20/25 or better was achieved in 18% of eyes. Mean±SE number of modifications required to achieve the final fit was 2±0. The resulting MicroVault elevations had a mean±SE (IQR) diameter of 3±0 (1) mm and depth of 263±45 (80) µm (data missing for 1 eye). A BCVA of 20/25 or better, and 20/32 or better, was achieved in 64% and 91% of cases, respectively, with a mean±SE comfortable wearing time of 14±1 hours.

CONCLUSION:

This sub-analysis provided valuable insights into fitting practices and visual outcomes with Zenlens utilizing Microvault technology, demonstrating its utility in enabling a precise fit in eyes with peripheral elevations that may impede lens fit or comfort.