Quality of life outcomes with the WaveLight Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers) Arthur Cummings MD1, Mathias Maus MD2, Dan.

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Presentation transcript:

Quality of life outcomes with the WaveLight Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers) Arthur Cummings MD1, Mathias Maus MD2, Dan Durrie MD3, Michael Gordon MD4, Ravaughn Williams OD5, James Gow MD6 1Wellington Eye Clinic, Dublin, Ireland; 2Sehrkraft Augenzentrum Maus, Cologne, Germany; 3Durrie Vision, Overland Park, KS, USA; 4Gordon-Weiss-Schanzlin Vision Institute, San Diego, CA, USA; 5Alcon Research Ltd., Fort Worth, TX, USA; 6Alcon Research Ltd., Lake Forest, CA, USA Arthur Cummings is a consultant to Alcon. This study was funded by Alcon. 1

Study Design Objective To evaluate quality of life outcomes with LASIK treatments for myopia using the WaveLight Refractive Suite Methods This was an open-label, post-market, prospective, single arm study Subjects aged ≥18 years underwent LASIK treatment with the WaveLight Refractive Suite Subjects were evaluated before surgery and at 1 day, 1 month, 3 months, and 6 months after surgery Typical ophthalmological assessments were performed. Additionally, subjects filled out a quality of life questionnaire called the Refractive Status and Vision Profile (RSVP)

Study Subjects Subjects had preoperative myopia of up to -12.0 D with or without astigmatism up to 6.0 D 104 subjects enrolled: 7 failed screening; 1 dropped out due to pregnancy 96 subjects in the Full Analysis Population

RSVP Questions 3 and 17 at 6 months post-op Not applicable Only contact lenses Mostly contact lenses, sometimes glasses About equally, glasses & contact lenses Only glasses Mostly glasses, sometimes contact lenses Question 3 In the past 4 weeks, to see far, I have used: 6 months after surgery, none of the subjects reported using any distance correction during the previous 4 weeks % Subjects Baseline 6 months Question 17 I worry about my vision: 6 months after surgery, 86% of subjects reported that they never or rarely worried about their vision % Subjects

RSVP Question 10 at 6 months post-op Rate your vision over the last 4 weeks, with no glasses or contact lenses 59.6 Baseline 6 months 99% subjects rated their UCVA QoV 8, 9, or 10 where 10 is perfect vision 27.7 25.0 21.3 20.0 11.3 11.7 7.5 7.5 3.8 2.5 0.0 0.0 0.0 0.0 0.0 0.0 1.1 0.0 0.0 1.3 0.0 Completely Blind Perfect Vision Vision Rating Mean ± SD Baseline: 3.6 ± 1.71 6 Months: 9.4 ± 0.78 Mean (SD) change from Baseline to 6 months 5.9 ± 1.84, P < 0.001 Baseline/Screening 6 Months Question 10: I have always worn glasses or contact lenses in the past 4 weeks, Count (%) Not ticked 76 (79.2) 94 (98.9) Ticked 20 (20.8) 1 (1.1)

Conclusions 6 Months after LASIK with the WaveLight® Refractive Suite: None of the subjects wore glasses or contact lenses for distance vision A high percentage of subjects never or rarely worried about their vision compared to baseline There was a significant improvement in vision compared to baseline