Abstract
Purpose :
To evaluate the tolerance to refractive error for a new full-range spectacle independence IOL.
Methods :
Ambispective (both prospective and retrospective) study at 3 sites in the USA. Patients with bilateral uncomplicated cataract extraction and implantation with a new full-range spectacle independence IOL were recruited for prospective 1-Month and 3-Month postoperative visits. Patients with history of chronic ocular disease (e.g., glaucoma, macular degeneration) or reduced visual potential (e.g., amblyopia, strabismus) were excluded. Monocular distance-corrected defocus visual acuity under photopic conditions was measured using the M&S Clinical Trials program. Data from preoperative and operative visits were collected retrospectively. Use of spectacles was assessed using the Patient-Reported Spectacle Independence Questionnaire (PRSIQ v2).
Results :
The study is ongoing. At interim analysis (n=10), mean monocular defocus was better than 0.2 logMAR (20/32) from +0.75 to -3.00 diopters of defocus. Monocular visual acuity within ±0.50 diopters range of defocus was 0.10 logMAR (20/25) or better with a peak of -0.07 logMAR at 0 diopters of defocus, indicative of BCDVA. Mean (SD) binocular uncorrected distance, intermediate (66cm), and near (40 cm) VA at 1 month was -0.06 (0.13), 0.06 (0.09), and 0.13 (0.17) logMAR. When evaluating the tolerance to refractive error, 100% (10/10) of patients saw 20/25 or better in the presence of +0.25D and +0.50D of defocus. In the presence of myopic defocus, 80% (8/10) saw 20/20 or better with –0.25 D of defocus, and 70% (7/10) saw 20/25 or better with –0.50D defocus. Eight out of ten patients reported not needing glasses for all three distances (distance, intermediate, and near vision), suggesting a high rate of spectacle independence.
Conclusions :
Early data indicate that the new IOL delivers full range of vision from distance to near and tolerance to residual refractive error as measured by defocus visual acuity.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.