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Clinical evaluation of visual, refractive and adverse events outcomes of a new monofocal IOL: six-month results

Poster Details

First Author: M.Teus SPAIN

Co Author(s):    G. Bolivar   J. Paz   A. Martinez              

Abstract Details

Purpose:

A prospective, multicenter, single group safety and performance clinical trial to demonstrate the long-term (3 years) visual acuity, refractive and adverse event outcomes for the Clareon IOL (Alcon). This paper presents 6-months interim results from subjects evaluated in a single site in Spain

Setting:

Hospital Universitario "Principe de Asturias", University of Alcalá, Alcalá de Henares, Madrid, Spain

Methods:

Subjects scheduled for bilateral cataract surgery with no ocular pathology other than cataract that could compromise visual function or the measurements are included. In each subject, the Clareon IOL (Model SY60WF) will be implanted in both eyes. Study examinations are performed preoperatively, 1 day, 1 week, 1 month, 6 months, 1, 2 and 3 years after cataract surgeries. Best corrected distance visual acuity (BCDVA), uncorrected distance visual acuity (UCDVA), manifest refraction, Slit lamp examination, ACD, PCO assessment and IOL observations will be carried out at each visit.

Results:

17 eyes of 34 patients enrolled at this site will be included. Six-month study visits evaluations are still ongoing and therefore results are not available yet. Results will be presented at the ESCRS in Paris.

Conclusions:

We will report the visual, refractive and IOL observations of the Clareon IOL in this cohort of study subjects. First conclusions of the study will be presented at the meeting.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

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