ESCRS - FP32.02 - A Multicenter, Non-Controlled And Open-Label Trial Following Subjects Implanted Bilaterally With The Toric Extended-Depth-Of-Focus Mini Well Toric Ready Intraocular Lens For 6 Months After The Second Eye Implant

A Multicenter, Non-Controlled And Open-Label Trial Following Subjects Implanted Bilaterally With The Toric Extended-Depth-Of-Focus Mini Well Toric Ready Intraocular Lens For 6 Months After The Second Eye Implant

Published 2023 - 41st Congress of the ESCRS

Reference: FP32.02 | Type: Free paper | DOI: 10.82333/syre-r797

Authors: Alfredo Castillo* 1 , Ramon Ruiz-Mesa 2 , Cedric Schweitzer 3 , Gerd U Auffarth 4

1Ophthalmology,University Hospital Quironsalud ,Madrid,Spain, 2Ophthalmology,Oftalvist CIO Jerez,Jerez de la Frontera,Spain, 3Ophthalmology,University Hospital Pelegrin,Bourdeaux,France, 4Ophthalmology,University Hospital Heidelberg,Heidelberg,Germany

Purpose

To evaluate the clinical performance of the Mini WELL Toric Ready intraocular lens, in particular, visual performance, rotational stability and  rate of severe visual distortions at 6 months post second implant.

Setting

Multicenter prospective clinical 

Department of Ophthalmology, University Hospital Quirónsalud Madrid, Madrid, Spain; 

Oftalvist Cio Jerez (Hospital HLA Jerez Puerta del Sur), Jerez de la Frontera, Ca´diz, Spain; 

Ophthalmology Department, University Hospital Pellegrin, Bordeaux Cedex, France;

The David J. Apple International Laboratory for Ocular Pathology, Department of Ophthalmology, University Hospital Heidelberg;

Methods

Multicentre prospective clinical trial including 40 patients with bilateral cataract surgery requiring correction of astigmatism. The mean  pre-operative total corneal astigmatism was 1.58 D (range from 0.64 to 3.64 ). They underwent cataract surgery with bilateral implantation of the MINI WELL TORIC (SIFI, Catania, Italy). Outcome measures were: visual acuity, defocus curve, reading performance, IOL rotation, IOL decentration,Quality of Vision (QoVQ and Aston Halometry), patient satisfaction and Task Evaluation Questionnaire.

 

 

Results

At the 6-month visit, the mean manifiest spherical refraction was -0.02 D (range -1.5, +1.5) with the mean manifiest cylinder -0.34 D (range 0.02-2.25 D) the mean absolute rotation was 6.9º and when combined with objective results was 5.3°. No ‘severe’ instances  were reported by QoV questionnaire,. The UDBVA was -0.01 logMAR (SD:0.09), DCBIVA was -0.03 logMAR (SD:0.09). Mean DCBNVA was +0.02 logMAR (SD 0.09) . Binocular defocus curves showed mean continuous vision of 0.10 logMAR or better from +0.75 D to -2.25 D. . The mean reading speeds was 133 words per minute (wpm) at 6-month visits. Halometry showed  that the visual disturbance rate was zero. Starbursts, multiple images and depth perception difficulties were relatively less common.

Conclusions

Mini WELL Toric Ready IOL showed acceptable rotational stability with absence of reported ‘visual distortion’ at 6 months. It provided refractive correction and  good overall visual performance, ensuring a range of vision from infinity to 44 cm,  Almost all the patients reached fluent reading speed and being able to read without glasses as well as reported being able to perform daily routine activities.