ESCRS - PP19.08 - Preliminary Results Obtained By The Accommodative Intraocular Lens Lumina Akkolens

Preliminary Results Obtained By The Accommodative Intraocular Lens Lumina Akkolens

Published 2022 - 40th Congress of the ESCRS

Reference: PP19.08 | Type: Free paper | DOI: 10.82333/w0tb-zj59

Authors: Jorge L Alio* 1 , Antonio Martinez-Abad 2 , Pilar Yebana 2 , Ana Belén Plaza 2

1Universidad Miguel Hernandez,Alicante,Spain;Vissum Miranza,Alicante,Spain, 2Research & Development Department,Vissum Miranza,Alicante,Spain

Purpose

The aim of this Phase I-II Clinical study was to evaluate the visual, refractive aberrometric outcomes, patient satisfaction and incidence of photic phenomena and complications of patients implanted with an innovative accommodative intraocular lens (AIOL) (Lumina Akkolens, International B.V.)

Setting

Vissum Grupo Miranza, Alicante, Spain

Methods

This is a longitudinal Phase I-II Clinical study composed of patients implanted with Lumina Akkolens due to cataract or a desire to achieve spectacle independence. Patients underwent a complete optometric and ophthalmologic examination before and after the surgery including measurement of visual acuities (reported in decimal notation), subjective refraction, defocus curve, ocular aberrometry by a pyramidal aberrometer (Osiris, CSO), photic phenomena perception by Halo & Glare simulator, as well as patient satisfaction assessment. The follow-up evaluation was between 3 and 12 months. The present is the interim report of a multicenter clinical trial.

Results

The study included 22 eyes of 12 patients (mean age of 60.9 ± 7.8 years; 55% females, 45% males). Postoperative visual outcomes showed a mean uncorrected distance visual acuity of 0.91±0.16 (range 0.50-1.20) and a mean uncorrected near visual acuity of 0.50±0.20 (range 0.20-0.80). Postoperative refractive outcomes were a mean sphere of +0.27±0.35D and a mean cylinder of -0.36±0.50D. The defocus curve showed a slow and sustained decrease of visual acuity. Ocular aberrations and photic phenomena perception were generally low. 62% of patients had total spectacle independence. Irreversible or very serious complications were not produced. The most common complication was the posterior capsule opacification.

Conclusions

The AIOL Lumina Akkolens provided excellent distance vision and functional near vision not inducing abnormal levels of aberrations or photic phenomena and good quality of clinical retinal image. The complications rate was low not observing any significant complication. These results will be confirmed and completed at the endpoint of the multicenter study analysis