Posters

Multi-center clinical evaluation of a new hydrophobic, single piece monofocal IOL

Poster Details

First Author: N.Bauer THE NETHERLANDS

Co Author(s):    F. van den Biggelaar   R. Nuijts   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 1-Year interim results.

Setting:

Multicenter, 18 sites, single group study.

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) was 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 are carried out at each visit

Results:

A total of 245 subjects were enrolled and 215 subjects were implanted. Of the 215 subjects implanted, 209 subjects were implanted bilaterally. At 1-year post-op, 205 subjects were still enrolled in the study. The mean age of the 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:

Sustainable good vision, stable refraction and mechanical stability outcomes with the Clareon IOL up to 1 year. Low PCO and Nd:YAG remain up to 1 year with less than 3% of eyes reporting clinical significant PCO and only 0.5%  requiring Nd:YAG treatment due to PCO. Based on these results the Clareon IOL can be considered Glistening Free at 1 year.

Financial Disclosure:

gains financially from 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, is employed by a for-profit company with an interest in the subject of the presentation