PURPOSE:

Scleral profilometry shows the sclera is spherical in shape for only 5.7% of eyes. A customizable scleral lens (SL), Zenlens, is available, which incorporates extensive customization for a precise fit in patients with a variety of corneal irregularities. Bi-Elevation technology creates two sagittal depth values inside the vaulting chamber to address scleral and limbal asymmetry, enabling uniform landing on the sclera. The purpose of this retrospective case review was to describe the real-world utilization of this SL; this sub-analysis focused on customization with Bi-Elevation.

METHODS:

Ten eye care practitioners (ECPs) from three countries provided a deidentified retrospective convenience sample of ≥5 cases 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, ocular symptoms, ECP satisfaction, lens fitting patterns, and number of follow-up visits 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). CRFs from six ECPs (23 eyes; 18 patients: 50% female; 50% male) utilizing Bi-Elevation, among other customizable parameters, were included in the present sub-analysis. The most common diagnosis was keratoconus (17/23 eyes); other reasons for SL utilization included high astigmatism and other corneal irregularities. The mean (SD) horizontal and vertical sagittal depth values were 4795 (409) and 5092 (448), respectively. A BCVA of 20/25 or better was achieved in 78% of cases (18/23 eyes). A mean (SD) comfortable wearing time of 13 (4) h was reported.

CONCLUSION:

This sub-analysis provided valuable insights into the fitting practices and visual outcomes with this customizable SL. The results demonstrated the utility of Bi-Elevation technology in enabling a precise fit in eyes with differences in elevation between the two major meridians.