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.

BACKGROUND: Despite the significant visual rehabilitation offered by scleral lenses, many individuals with keratoconus continue to experience suboptimal vision. Commonly reported symptoms include residual irregular blur, glare, halos, and monocular diplopia, which can substantially reduce quality of life. This case series explores the use of wavefront-guided (wfg)-optical correction in long-term scleral lens wearers with persistent visual disturbances.

Case Description: Four patients with a history of keratoconus were screened for residual higher order aberrations (HOAs) using a commercial aberrometer (OVITZ xwave, Rochester, NY, USA); all aberrometry results were reported at a 5.5 mm pupil diameter. After achieving a stable finalized fit with Zenlens scleral lenses (Bausch + Lomb), fiducial markings were added to the lens ("standard lens"). Residual HOAs and the precise position of the lens on-eye were measured with the aberrometer. A custom-designed wfg-optic was then added (Zenlens Chroma; "final wfg-lens"). All cases included at least 30 days of follow-up each.

Patient 1, a 42-year-old Arab male, had a best-corrected visual acuity (BCVA) of 20/25 OD and 20/50 OS with the standard lens. HOA root mean square (HOARMS) was 1.03 µm OD and 1.61 µm OS. After final wfg-lens fitting, BCVA was 20/20 OD and 20/25−1 OS; HOARMS was 0.19 µm OD and 0.34 µm OS, corresponding to an improvement of 81.5% OD and 78.9% OS.

Patient 2, a 24-year-old Arab male, had a BCVA of 20/20 OD and 20/25 OD with the standard lens. HOARMS was 0.79 µm OD and 0.73 µm OS. After final wfg-lens fitting, BCVA was 20/20 OD and 20/20 OS; HOARMS was 0.31 µm OD and 0.20 µm OS, corresponding to an improvement of 60.7% OD and 72.6% OS.

Patient 3, a 38-year-old white male, had a BCVA of 20/20 OD with the standard lens. HOARMS was 0.80 µm OD. After final wfg-lens fitting, BCVA was 20/20 OS; HOARMS was 0.29 µm OD, corresponding to an improvement of 63.8% OD.

Patient 4, a 74-year-old white male, had a BCVA of 20/50 OS with the standard lens. HOARMS was 1.39 µm OS. After final wfg-lens fitting, BCVA was 20/25 OS; HOARMS was 0.23 µm OS, corresponding to an improvement of 83.4% OS.

All patients reported significant improvement in their subjective vision. There was an average HOARMS improvement of 73.3% across all eyes.

CONCLUSIONS: Wfg-scleral lenses are an effective method for reducing HOAs and can significantly improve patients' vision performance and quality of life.