Postoperative uncorrected visual acuity (UCVA) vs preoperative best corrected visual acuity (BCVA) with the WaveLight Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers)

Session Details

Session Title: Femtosecond Small Lenticule Extraction II

Session Date/Time: Tuesday 08/09/2015 | 16:30-18:30

Paper Time: 17:28

Venue: Room 17

First Author: : A.Cummings IRELAND

Co Author(s): :    M. Maus   D. Durrie   M. Gordon   R. Williams   J. Gow        

Abstract Details

Purpose:

To evaluate postoperative UCVA compared to preoperative BCVA with LASIK treatments for myopia using the WaveLight Refractive Suite.

Setting:

Prospective, post-market, and open label trial at 4 sites, 2 each in US and Europe. 1.Durrie Vision, Overland Park KS, USA 2.Gordon-Weiss-Schanzlin Vision Institute, San Diego CA, USA 3.Wellington Eye Clinic, Dublin, Ireland 4.Sehkraft Augenzentrum Maus, Cologne, Germany

Methods:

Myopic subjects 18 years of age or older underwent LASIK treatment with the WaveLight Refractive Suite. Subjects completed visits preoperatively and 1 day, 1 month, 3 months, and 6 months postoperatively. Binocular UCVA and BCVA were measured with an ETDRS chart at 4 meters. Non-inferiority of postoperative UCVA at 1 month to preoperative BCVA was judged against a margin of 0.1logMAR. After the non-inferiority hypothesis was confirmed, superiority was tested at 1 month, 3 months, and 6 months postoperative UCVA compared to preoperative BCVA.

Results:

Ninety six subjects completed the study and 73 subjects were analyzed in the per-protocol set. The difference between postoperative UCVA and preoperative BCVA at 1 month was LS adjusted mean of -0.0601, standard error (SE) of ±0.0201, P = 0.0031. The difference between postoperative UCVA and preoperative BCVA at 3 months was LS adjusted mean of -0.0684, SE of ± 0.0201, P = 0.0008. The difference between postoperative UCVA and preoperative BCVA at 6 months was LS adjusted mean of -0.0719, SE of ± 0.0201, P = 0.0004.

Conclusions:

Postoperative UCVA was significantly superior to preoperative BCVA at 1 month, 3 months, and 6 months postoperatively with LASIK treatment for myopia using the WaveLight Refractive Suite.

Financial Interest:

One of the authors is employed by a for-profit company with an interest in the subject of the presentation, One of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented