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Clinical evaluation of visual, refractive and adverse events outcomes of a new monofocal IOL in an Australian population: 1 year results

Poster Details

First Author: T.Roberts AUSTRALIA

Co Author(s):    T. Roberts   U. Bhatt   A. Martinez              

Abstract Details

Purpose:

Prospective, multicenter, single group safety and performance clinical trial to evaluate the long-term (3 years) visual and refractive outcomes with the new Clareon IOL (Alcon). This paper presents 1-Year interim results from subjects evaluated in Australia.

Setting:

Multicenter, 18 sites, single group study. Reporting data collected from 2 sites in Australia

Methods:

Subjects scheduled for bilateral cataract surgery with no ocular pathology other than cataract that could compromise visual function or the measurements are included. Bilateral implantation with the Clareon IOL (Model SY60WF) was performed in all study subjects. Study examinations preoperatively, at 1-day, 1-week, 1-month, 6-months and 1 year after cataract surgeries are included in this paper. Best corrected distance visual acuity (BCDVA), uncorrected distance visual acuity (UCDVA), manifest refraction, Slit lamp examination, ACD, PCO assessment and IOL observations were carried out at each visit.

Results:

The mean age of the overall study implanted cohort was 72.1 (8.07) years and 59% females. At 1 year, average monocular BCDVA remains 0.0logMAR with 85% of eyes having MRSE 0.50D or less in both eyes. Monocular BCDVA 20/25 or better is observed in at least 94% of eyes. Glistenings Grade 0 are reported in 99.5% of eyes at 1 year.

Conclusions:

Excellent vision, stable refraction and mechanical stability outcomes are observed with the Clareon IOL up to 1 year. Low PCO and Nd:YAG remain up to 1 year and Glistenings grade zero observed at these 2 sites.

Financial Disclosure:

gains financially from product or procedure presented, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, is employed by a for-profit company with an interest in the subject of the presentation

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