One Year Outcomes Of The Phase Iii Clinical Study On The Lumina Accommodative Intraocular Lens
Published 2025 - 43rd Congress of the ESCRS
Reference: FP17.01 | Type: Free paper | DOI: 10.82333/sxht-mt60
Authors: Filippo Lixi* 1 , Claudia Corda 1 , Giulia Coco 2 , Giovanna Carnovale-Scalzo 3 , Alessandra Mancini 3 , Maria Angela Romeo 3 , Vincenzo Scorcia 3 , Giuseppe Giannaccare 1
1Department of Surgical Sciences,University of Cagliari,Cagliari,Italy, 2Department of Clinical Sciences and Translational Medicine,University of Rome Tor Vergata,Rome,Italy, 3Department of Ophthalmology,University Magna Graecia of Catanzaro,Catanzaro,Italy
Purpose
To report the outcomes of phase III Clinical Study with the Lumina Accommodative Intraocular Lens sulcus based (AIOL) at 12-month postoperative follow-up.
Setting
Cornea, Cataract, and Refractive Surgery Unit at Vissum Miranza Alicante, Spain
Methods
Prospective, interventional, non-comparative, longitudinal and consecutive study. 25 patients with a 12-month postoperative evaluation including visual and refractive variables, defocus curve, objective accommodation, contrast sensitivity function, retinal optical quality assessment and PROMs (patients reports outcomes measures). The Wilcoxon test was applied for all longitudinal comparisons.
Results
Distance and near mean postoperative uncorrected visual acuity was 0.06±0.15 and 0.27±0.15 LogMAR. Defocus curves showed a corrected vision of -0.01±0.06 distance, 0.18±0.11 intermediate and 0.38±0.13 near. Subjective depth of focus, determined from the defocus curve, was 137±0.74, 2.05±0.75, and 3.63±0.68 D for visual acuities of 0.10, 0.20, and 0.40 logMAR. The contrast sensitivity function showed better results than normal values and the optical quality a mean point spread function of 0.23 mm. In the PROMs over 87% of patients reported mild or no difficulties in uncorrected near vision. 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 AIOL provides very good distance vision maintaining a suitable contrast sensitivity and optical quality. Near vision was restored also conveniently. The lens demonstrated both accommodative and pseudoaccommodative functions. The lack of complications other than the posterior capsular opacity, confirms the adequate performance of this implant and the preservation of accommodation after capsulotomy.