One-Year Outcomes Of The Phase Iii Clinical Study On The Lumina Accommodative Intraocular Lens

The aim of this Phase III Clinical study was to evaluate the visual and refractive results, aberrometric and accommodative outcomes, patient satisfaction and complications rate of patients implanted with an innovative accommodative intraocular lens (AIOL) (Lumina Akkolens, International B.V.) during a one-year follow-up period.

1. Vissum Grupo Miranza, Alicante, Spain.
2. Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain

Prospective, interventional, non-comparative, longitudinal and consecutive study involving patients eligible for cataract surgery who opted for the implantation of the Lumina AIOL. It was composed by 25 patients aged 40 to 81 years who undergone to a complete preoperative ophthalmologic examination and postoperative examinations at 1, 3, 6 and 12 months performing the following test: distance and near visual acuities (VA), ocular refraction, defocus curve, accommodative response and ocular aberrations measured by the new open field aberrometer (OFA-Osiris, CSO, Italy), contrast sensitivity assessment, PROMs (quality of vision and quality of life reported by the patients), and slit lamp and fundus examination reporting the complications rate

Uncorrected distance VA and uncorrected near VA improved after Lumina implantation (p<0.05), 0.06±0.15 and 0.27±0.15 LogMAR respectively. Mean sphere 0.01±0.60 diopters (D) and mean cylinder -0.40±0.41 D at 12 months. Defocus data maximum VA -0.01±0.06 LogMAR distance, and VA 0.18±0.11 and 0.38±0.13 intermediate and near vision, respectively. Mean accommodative response 0.54 D. Contrast sensitivity presented suitable results. Over 87% of patients reported no/mild difficulties. Severe persistent complications were not observed. The incidence of posterior capsule opacification occurred in 26% of eyes, which were treated by YAG capsulotomy observing an improvement of uncorrected near VA (p 0.018) related to optimization of accommodation.

The AIOL Lumina Akkolens provided excellent distance vision and functional near vision not altering the visual quality and presenting good patient satisfaction. The change in the dioptric power of the eye between the fixation at far and near distance by OFA confirmed the presence of real accommodation, which seems to improve after YAG capsulotomy. The lack of relevant complications other than the relatively high incidence of posterior capsular opacity, confirms the safety of this implant in the ciliary sulcus. Further multicentric studies, already in progress, are necessary to confirm the outcomes reported in the current study.