1. 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

2. 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)

3. Study Subjects
Subjects had preoperative myopia of up to 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

4. 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

5. 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)

6. 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