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

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 ( ≤ 0.033). No significant changes in Strehl ratio and total root mean square were detected ( ≥ 0.182). Binocular contrast sensitivity was better with spectacles than with the fitted CSCL at all frequencies ( ≤ 0.048), but the change in monocular did not reach statistical significance for 18 cycles per degree ( = 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.