Presentation of Detlev Breyer (MD) at the ASCRS 2017 in Los Angeles. Title: Quality of Life Patient Questionnaire after Refractive Lenticule Extraction (ReLEx) SMILE. Comparison of the First and Last Consecutive Cases.

1. Quality of Life Patient Questionnaire after
Refractive Lenticule Extraction (ReLEx) SMILE.
Comparison of the First and Last Consecutive Cases.
E. Taylor, D. Breyer, H. Kaymak, K. Klabe, P. Hagen, F. Kretz, G. Auffarth

2. Financial Disclosure
Breyer, Kaymak & Klabe Eye Surgery and Premium Eyes are Consulting, Study Center & MAB for:
Abott, Alcon, AlimeraSciences, Allergan, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron, Geuder, iOptics, LensAR,
Novartis, Oculentis, Oertli, Revision Optics, Santen, Staar Surgical, Thea, Topcon, Visufarma, Ziemer

3. ReLEx SMILE: Improvements in Treatment Process
• Since first ReLEx SMILE surgery several adjustments of treatment steps / laser
parameters have been made:
• Question: Do these factors have a measureably positive impact on the visual outcome?
group First Last
number of patients (consecutive cases) 32 32
SMILE surgery of 2nd eye performed as of… 01.02.2012 01.02.2016
Visumax
parameters
spot-and-track
value [µm]
cap / lenticule 3.0 4.5
lenticule border 2.5 2.0
spot energy [nJ] 150 170
maximum cap thickness [µm] 140 150
myopia of -3.0D or more: increase ΔSE=SE(target)-
SE(pre) by 10% in order to compensate undercorrection
no yes
surgery
steps
flush out interface with cortisone no yes
corneal flattening via index finger no yes
learning
curve
number of hitherto executed SMILE surgeries 0 1150

4. 0%
25%
50%
75%
100%
loss3
ormore
loss2
loss1
unchanged
gain1
gain2
gain3
ormore
Percentageofeyes[%]
∆CDVA [Snellen Lines]
Safety: CDVA(3M) - CDVA(pre)
Safety
group #Augen ∆CDVA
First first cases 57 0.01 ± 0.05
Last last cases 58 -0.04 ± 0.09
 No eye with loss of 2 or more lines
 Last cases slightly (by approx. 2.5 letters) but significantly (p<0.05) better regarding ∆CDVA
 Similarly small but significant advantages also present in case of predictability and efficacy
Question: Do these advantages also manifest themselves as an increase of
patient satisfaction with respect to quality of life?

5. Quality of Life Impact of Refractive Correction (QIRC)
Questionnaire
Systematic creation of the QIRC via stepwise process:
1. Collecting 647 initial question from:
o already known (partially vision-related) questionnaires for quality of life as well as
o proposals of 63 health care professionals (physicians, optometrists, psychologists, …)
2. Reduction to 115 items via expert panel
3. Reduction to 90 items via first test series
4. Test of 90-item pilot questionnaire: 316 patients in 18 centers in the UK
5. Conducting a Rasch analysis in order to filter out subset of 20 items
6. Translation into german via professional translation company
(including back translation for consistency check)

6. QIRC Questionnaire & Corneal Refractive Surgery
• Use within studies related to quality of life after LASIK and SMILE

7. 0%
25%
50%
75%
100%
Don’tdrivefor
reasonsother
thanmyvision
Noneatall
Alittlebit
Amoderateamount
Alot
Somuchthat
Ican’tdo
thisactivity
Percentageofpatients[%]
Question 1: How much difficulty do you have driving in glare conditions?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 1
 No significant (p<0.05) differences
group Rasch-Score
First first cases 53 ± 11
Last last cases 54 ± 9

8. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
None
Alittlebit
Amoderateamount
Quitealot
Extreme
Percentageofpatients[%]
Question 5: How much trouble is not being able to see when you wake up; e.g. to see alarm
clock?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 5
 First cases with significantly (p=0.04<0.05) better outcome (probably purely statistical effect)
group Rasch-Score
First first cases 59 ± 0
Last last cases 57 ± 5

9. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
Notatall
Alittlebit
Amoderateamount
Quitealot
Extremely
Percentageofpatients[%]
Question 8: How concerned are you about the initial and ongoing cost to buy your current
refractive surgery?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 8
 No significant (p<0.05) differences
group Rasch-Score
First first cases 55 ± 12
Last last cases 56 ± 12

10. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
Notatall
Alittlebit
Amoderateamount
Quitealot
Extremely
Percentageofpatients[%]
Question 9: How concerned are you about the cost of unscheduled maintenance of your
refractive surgery?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 9
 No significant (p<0.05) differences
group Rasch-Score
First first cases 56 ± 10
Last last cases 59 ± 5

11. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
Notatall
Alittlebit
Amoderateamount
Quitealot
Extremely
Percentageofpatients[%]
Question 11: How concerned are you about your vision not being as good as it could be?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 11
 No significant (p<0.05) differences
group Rasch-Score
First first cases 52 ± 12
Last last cases 52 ± 12

12. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
Never
Occasionally
Fairlyoften
Veryoften
Always
Percentageofpatients[%]
Question 19: During the past month, how much of the time have you felt able to do the things
you want to do?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Frage 19
 No significant (p<0.05) differences
group Rasch-Score
First first cases 29 ± 15
Last last cases 31 ± 15

13. 0%
25%
50%
75%
100%
Don’tknow/
Notapplicable
Never
Occasionally
Fairlyoften
Veryoften
Always
Percentageofpatients[%]
Question 20: During the past month, how much of the time have you felt eager to try new
things?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Question 20
 No significant (p<0.05) differences
group Rasch-Score
First first cases 35 ± 15
Last last cases 40 ± 16

14. Summary:
• Minimum advantages for last SMILE patients with respect to
safety, predictabilty and efficacy compared to first SMILE patients
• No measurable differences in quality of life assessed with QIRC
questionnaire
Experience from practicle implementation of QIRC:
• Question in part probably influenced by to many factors:
Example: „Question 18: During the past month, how much of the
time have you felt happy? “
• Some questions turned out to be quite hard to answer for
patients:
Example: „Question 15: During the past month, how much of the
time have you felt that you think others see you the way you
would like them to (e.g. intelligent, sophisticated, successful,
cool, etc)?
Results:
Quality of Life Impact of Refractive Correction (QIRC) – Total Score
group Rasch-Score
First first cases 51 ± 5
Last last cases 51 ± 4
No significant differences in total score

15. Thank you very much for your attention!