PURPOSE: This study aimed to generate early real-world insights into eye care practitioner (ECP) experience with a custom wavefront-guided scleral lens system (wfgSL; Zenlens Chroma) designed to reduce higher order aberrations (HOAs). Fitting involves stabilizing the traditional scleral lens (tSL; Zenlens), then using wavefront (wf)-aberrometry to measure residual HOAs and design the wfgSL surface with inverse aberrations.

METHODS: Four SL-experienced ECPs from the USA provided a deidentified retrospective set of cases fit with the wfgSL using OVITZ (OV; n=3) or Nidek (ND; n=1) wf-aberrometers. ECPs used a standardized case report form to document clinical outcomes including best-corrected visual acuity (BCVA), root mean square (RMS) to evaluate aberration magnitude, comfortable wearing time, and adverse events; ECPs also reported their satisfaction with the wfgSL. Central institutional review board exemption was received for this protocol.

RESULTS: The main study analysis included 47 OV-fit cases of 28 patients (18 male, 10 female; mean±SD age 47.0±14.4 years) confirmed to have final wfgSL fits with data available at matched pupil size (5.5 mm). Analysis exclusions were 24 OV-fit cases, most commonly due to loss to follow-up, and cases utilizing ND (n=9) which were found to be ineligible due to a wf-aberrometer incompatibility identified during the study. For the 47 OV-fit cases analyzed, the most common diagnosis was keratoconus (37 eyes; 78.7%). Baseline best-spectacle corrected visual acuity (BSCVA) was 20/40 or better for 32/47 (68.1%) eyes. With final lens fits, BCVA was 20/40 or better for 43/47 (91.5%) and 46/47 (97.9%) eyes with the tSL and the wfgSL, respectively. Mean±SD RMS (for corrected pupil value 5.5 mm; n=47) was 0.75±0.34 and 0.33±0.15 with the tSL and wfgSL, respectively. Mean±SD % RMS improvement (n=47) with the wfgSL vs tSL was 53.8%±20.3%. Comfortable wearing time with the wfgSL (mean±SD) was 14.3±2.2 hours. On a 1–10 scale (1=very dissatisfied/difficult; 10=very satisfied/easy; n=46 cases), ECPs reported high satisfaction (mean±SD) with lens outcomes (9.9±0.5), degree of customization (10.0±0.0), process of customization (10.0±0.0), and ease of customization (9.7±0.9). No adverse events were reported in any case.

CONCLUSIONS: The findings of this study demonstrate real-world effectiveness of Zenlens Chroma in reducing HOAs and thus improving vision outcomes in patients with corneal irregularities. ECPs were highly satisfied with the lens customization and outcomes.