Trial Outcomes & Findings for Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax (NCT NCT02987660)
NCT ID: NCT02987660
Last Updated: 2019-01-14
Results Overview
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
TERMINATED
NA
21 participants
Month 3
2019-01-14
Participant Flow
Subjects were recruited from 1 study center located in France.
Of the 21 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (20).
Participant milestones
| Measure |
LASIK
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
LASIK
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
|---|---|---|
|
Overall Study
Study terminated by sponsor
|
10
|
10
|
Baseline Characteristics
Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax
Baseline characteristics by cohort
| Measure |
LASIK
n=10 Participants
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
n=10 Participants
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: ITT with non-missing data
Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Outcome measures
| Measure |
LASIK
n=10 Eyes
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
n=14 Eyes
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
|---|---|---|
|
Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months
|
60 percentage of eyes
Interval 26.2 to 87.8
|
100.0 percentage of eyes
Interval 76.8 to 100.0
|
SECONDARY outcome
Timeframe: Month 3Population: ITT with non-missing data
Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.
Outcome measures
| Measure |
LASIK
n=10 Eyes
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
n=14 Eyes
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
|---|---|---|
|
Mean Manifest Refraction Cylinder at 3 Months
|
-0.575 Diopters
Standard Deviation 0.4091
|
-0.232 Diopters
Standard Deviation 0.1539
|
SECONDARY outcome
Timeframe: Month 3Population: ITT with non-missing data
Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in "logarithm of the minimum angle of resolution" (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed.
Outcome measures
| Measure |
LASIK
n=10 Eyes
Topography Guided LASIK with WaveLight EX500 excimer laser system in bilateral surgery
|
SMILE
n=14 Eyes
Small incision lenticular extraction (SMILE) with VisuMax laser in bilateral surgery
|
|---|---|---|
|
Mean Uncorrected Visual Acuity (UCVA) at 3 Months
|
-0.100 logMAR
Standard Deviation 0.1360
|
-0.164 logMAR
Standard Deviation 0.0769
|
Adverse Events
LASIK
SMILE
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Global Brand Medical Affairs Lead, CDMA Surgical
Alcon, A Novartis Division
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER