Superior Intermediate And Uncompromised Distance Quality Of Vision With A Purely Refractive Extended Depth Of Focus Intraocular Lens.

The purpose of this study was to evaluate the quality of vision of a new purely refractive extended depth of focus (EDF) Intraocular lens (IOL).

Six sites in Australia and New Zealand.

This was a prospective, multi-center, randomized, bilateral, subject/evaluator masked clinical study. All subjects were bilaterally implanted with the EDF test (Model DEN00V, N=60) or an enhanced monofocal control (Model ICB00, N= 58) IOL. Monocular best-corrected distance vision (BCDVA) at 100% and 25% contrast, monocular difference in mesopic with and without glare contrast sensitivity (CS), visual symptoms, distance-corrected intermediate
(DCIVA) were evaluated at 3- and 6-month postoperative visits. Visual symptoms were evaluated with the Patient Reported Visual Symptoms Questionnaire (PRVSQ). Visual acuity Mean ± Stdev are reported in logMAR and Snellen notations for the first implanted eyes.

Mean DCIVA showed statistically significant improvement with 20% more eyes achieving 6/9.5 or better. BCDVA was -0.06 ± 0.08 and -0.05 ± 0.08 (~ 6/4.8) and 25% BCDVA was 0.16 ± 0.10 and 0.13 ± 0.10 (~6/9.5) in test and control groups, respectively. The mean difference in CS was 0.04 vs. 0.07 at 1.5 cpd, -0.04 vs. -0.02 at 3.0 cpd, -0.09 vs. -0.11 at 6 cpd, -0.08 vs. -0.05 log units at 12 cpd. Similar percentage of subjects that did not experience or experienced not bothersome or slightly bothersome visual symptoms for both lens models with 92% vs. 97% for halos, 95% vs. 100% for starbursts, 95% vs. 98% for glare, 93% vs. 97% for poor low light vision in the test vs. control groups, respectively.

Subjects implanted with the new purely refractive EDF IOL demonstrated statistically superior intermediate performance with excellent distance visual acuity under high and low contrast conditions, low levels of visual symptoms and excellent contrast sensitivity.