One-Year Outcomes of the Phase III Clinical Study on the Lumina Accommodative Intraocular Lens

Abstract

PURPOSE: To report the outcomes of a Phase III Clinical Study with the sulcus-based Lumina accommodative intraocular lens (IOL) (Akkolens, Clinical BV) with 12 months of postoperative follow-up. METHODS: This was a prospective, interventional, non-comparative, longitudinal and consecutive study developed at the Cornea, Cataract, and Refractive Surgery Unit at Vissum, Grupo Miranza, Alicante, Spain. It was composed of 25 patients who were bilaterally implanted with the Lumina accommodative IOL and had undergone a 12-month postoperative evaluation including visual and refractive variables, defocus curve, objective accommodation, contrast sensitivity function, retinal optical quality assessment, and patient-reported outcome measures (PROMs). The Wilcoxon test was applied for all longitudinal comparisons. RESULTS: All distance and near visual acuities improved after the surgery (P < .05). Distance and near mean postoperative uncorrected visual acuities were 0.06 ± 0.15 and 0.27 ± 0.15 logarithm of the minimum angle of resolution (logMAR), respectively. The defocus curve exhibited a corrected vision of -0.01 ± 0.06 at distance, 0.18 ± 0.11 at intermediate, and 0.38 ± 0.13 at near vision. The subjective depth of focus, as determined from the defocus curve, was 1.37 ± 0.74, 2.05 ± 0.75, and 3.63 ± 0.68 diopters (D) for visual acuities of 0.10, 0.20, and 0.40 logMAR. The mean objective accommodation was -0.65 ± 0.69 D. The contrast sensitivity function exhibited better results than normal values and the optical quality revealed a mean point spread function of 0.23 µm. In the PROMs, more than 87% of patients reported mild or no difficulties in uncorrected near vision. The complication rate was low; only posterior capsule opacity and epithelial type were common but being successfully treated by laser capsulotomy improved the uncorrected near vision (P = .018). PROMs also revealed a perceived good functional result in far and near vision performance, with minimal or negative abnormal light visual phenomena. CONCLUSIONS: The Lumina sulcus-based accommodative IOL provides generally good distance vision maintaining a suitable contrast sensitivity and optical quality. Near vision also was restored conveniently. The lens demonstrated both accommodative and pseudoaccommodative functions. The lack of complications other than posterior capsular opacity confirms the adequate performance of this implant and the preservation of accommodation after capsulotomy.