PURPOSE:

When patients with complex corneal conditions also require presbyopic correction, custom scleral lens (SL) options become increasingly important. Zenlens (an SL) incorporates design flexibility and extensive customization capabilities to help eye care practitioners (ECPs) achieve a precise fit in patients. This SL also provides the opportunity for multifocal optics, achieved using decentered optics that align the near zone over the visual axis (slightly nasal and superior for each eye) to help provide clear vision. Documented real-world evidence with Zenlens is limited; therefore, a retrospective multi-country case review was performed to gain insight into real-world visual outcomes and lens-fitting practices. This sub-analysis focused on multifocal lenses.

METHODS:

Ten 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 lens fitting patterns, best-corrected visual acuity (BCVA), comfortable wearing time, and number of modifications required to achieve a successful fit. The protocol received central IRB exemption. Descriptive statistics are reported.

RESULTS:

The full analysis set included CRFs from 10 ECPs (62 eyes; 45 patients). This sub-analysis included CRFs from four ECPs utilizing Zenlens with multifocal optics and included five patients (three female, two male); nine eyes (OU in four patients; OD in one patient). The most common diagnosis was keratoconus (three patients; five eyes). Reasons for using the lenses included unsatisfactory outcomes with other lenses, including poor visual outcomes and a lack of customization options. Results are reported for all patients/eyes. Mean±SE add power, near zone diameter, and pupil diameter were 1.78±0.25 D, 2±0 mm, and 3±0 mm, respectively. A BCVA at distance of 20/25 or better, and 20/32 or better, was achieved in 67% and 100% of cases, respectively. Corrected near visual acuity of 20/20 or better, and 20/32 or better, was achieved in 67% and 89% of cases, respectively. Mean±SE comfortable wearing time was 12±1 hours. Mean±SE number of modifications required to achieve the final fit was 2±0. No adverse events were reported.

CONCLUSION:

This sub-analysis provided valuable insights into real-world visual outcomes and lens fitting practices with Zenlens using multifocal optics.