# Pilot Study Evaluating the Early Clinical Outcomes Obtained with a Novel, Customized, Multifocal Corneo-Scleral Contact Lens for Presbyopia Correction

## TL;DR

A new customized contact lens for presbyopia improved vision at different distances, with results comparable to other multifocal lenses.

## Contribution

A novel customized multifocal corneo-scleral contact lens was evaluated for presbyopia with functional visual recovery.

## Key findings

- The lens improved distance and intermediate visual acuity in most patients.
- Stereopsis and contrast sensitivity showed acceptable reductions similar to other multifocal lenses.
- No significant changes in Strehl ratio or total root mean square were observed.

## Abstract

Background: The objective was to preliminarily evaluate the short-term clinical outcomes obtained in presbyopic patients with a novel, multifocal, customized corneo-scleral contact lens (CSCL). Methods: A total of 11 presbyopic subjects (age 45–80 years, corrected-distance visual acuity ≤ 0.1 LogMAR, near addition ≥ +1.00 D) were recruited and fitted with a multifocal corneo-scleral contact lens in this pilot study. Pre-fitting evaluations included stereopsis, contrast sensitivity (CS), and ocular aberrometry, with follow-up assessments conducted at 20 min and 1-month post-fitting. The defocus curve was also measured to assess visual performance across varying distances. Results: Twenty-two eyes from 11 participants (53.9 ± 4.7 years, 10 female) were included in this study. Significant changes were observed post-fitting for primary and secondary spherical aberration, coma, and stereopsis (p ≤ 0.033). No significant changes in Strehl ratio and total root mean square were detected (p ≥ 0.182). Binocular contrast sensitivity was better with spectacles than with the fitted CSCL at all frequencies (p ≤ 0.048), but the change in monocular did not reach statistical significance for 18 cycles per degree (p = 0.109). All patients and 90.9% of patients achieved a visual acuity of 0.0 LogMAR or better at distance and at intermediate, respectively, and 91.8% achieved 0.3 LogMAR or better for near vision. Conclusions: The customized CSCL evaluated provided functional recovery of visual quality across distances, with acceptable reductions of CS and stereopsis that are comparable to those reported for other multifocal contact lenses.