European, Multicenter, Prospective, Non-comparative Clinical Evaluation of an Extended Depth of Focus Intraocular Lens.

PURPOSE: To evaluate clinical and safety results obtained with an extended depth of focus (EDOF) intraocular lens (IOL).

METHODS

In this European, multicenter, prospective, uncontrolled, interventional study, 77 patients were enrolled in the study, 71 patients received bilateral implantation of the Mini Well Ready EDOF IOL (SIFI S.p.A.), and 68 patients completed the study and were evaluated 2 to 4 months postoperatively. Each clinical examination recorded uncorrected (UDVA) and corrected (CDVA) distance visual acuity, uncorrected (UIVA) and distance-corrected (DCIVA) intermediate visual acuity, and uncorrected (UNVA), distance-corrected (DCNVA), and corrected (CNVA) near visual acuity. A defocus curve from +2.00 to -5.00 diopters (D) was obtained, contrast sensitivity and reading ability were assessed, and the perception of dysphotopsia was evaluated.

RESULTS

Mean binocular visual results showed UDVA, UIVA, and UNVA values of -0.01 ± 0.15, 0.03 ± 0.10, and 0.10 ± 0.11 logMAR, respectively. Mean binocular defocus curve demonstrated a visual acuity of 0.30 logMAR or better from +2.00 to -3.00 D. Mean photopic contrast sensitivity values were 1.86, 2.18, 1,97, 1.51, and 1.17 at 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree, respectively. A fluent reading speed of 80 words per minute was reached at 0.5 logRAD by 95.31% of patients without distance correction. The mean halo size was 33.06 ± 14.25, mean halo intensity was 38.00 ± 18.51, mean glare size was 23.85 ± 10.43, and mean glare intensity was 42.23 ± 13.22. One postoperative complication, a moderate photophobia, was observed and classified as related to the lens.

CONCLUSIONS

The Mini Well Ready EDOF IOL provides good visual acuity across various distances and functional reading ability provided at a near range, and delivers an enhanced contrast sensitivity while causing a low incidence of photic phenomena. [J Refract Surg. 2020;36(7):426-434.].