Trial Outcomes & Findings for Topo-guided LASIK and Photorefractive Keratectomy vs Wavefront LASIK and Photorefractive Keratectomy (NCT NCT03075176)
NCT ID: NCT03075176
Last Updated: 2023-07-17
Results Overview
Uncorrected visual acuity will be tested pre-operatively through month 12
TERMINATED
NA
39 participants
12 months
2023-07-17
Participant Flow
39 participants were randomized, one participant withdrew, 38 completed wavefront surgery on one eye and topoguided surgery on the other eye. A total of 76 eyes were treated.
Unit of analysis: eyes
Participant milestones
| Measure |
Wavefront Optimized LASIK
Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen).
Wavefront optimized LASIK: Wavefront optimized laser vision correction
Topography-guided LASIK: Topography-guided laser vision correction
|
Wavefront Optimized Photorefractive Keratectomy
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen).
Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction
Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction
|
Topography-guided LASIK
Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen).
Wavefront optimized LASIK: Wavefront optimized laser vision correction
Topography-guided LASIK: Topography-guided laser vision correction
|
Topography-guided Photorefractive Keratectomy
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen).
Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction
Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18 18
|
20 20
|
18 18
|
20 20
|
|
Overall Study
COMPLETED
|
18 18
|
20 20
|
18 18
|
20 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Wavefront Optimized LASIK
n=18 Eyes
Participants who chose to have LASIK surgery were assigned to have Wavefront optimized LASIK in one eye and Topography-guided LASIK in the other eye (randomly chosen).
Wavefront optimized LASIK: Wavefront optimized laser vision correction
Topography-guided LASIK: Topography-guided laser vision correction
|
Wavefront Optimized Photorefractive Keratectomy
n=20 Eyes
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Wavefront optimized Photorefractive Keratectomy in one eye and Topography-guided Photorefractive Keratectomy in the other eye (randomly chosen).
Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction
Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction
|
Topography-guided LASIK
n=18 Eyes
Participants who chose to have LASIK surgery were assigned to have Topography-guided LASIK in one eye and Wavefront optimized LASIK in the other eye (randomly chosen).
Wavefront optimized LASIK: Wavefront optimized laser vision correction
Topography-guided LASIK: Topography-guided laser vision correction
|
Topography-guided Photorefractive Keratectomy
n=20 Eyes
Participants who chose to have Photorefractive Keratectomy surgery were assigned to have Topography-guided Photorefractive Keratectomy in one eye and Wavefront optimized Photorefractive Keratectomy in the other eye (randomly chosen).
Wavefront optimized Photorefractive Keratectomy: Wavefront optimized laser vision correction
Topography-guided Photorefractive Keratectomy: Topography-guided laser vision correction
|
Total
n=76 Eyes
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Eyes
n=18 Eyes
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=18 Eyes
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=76 Eyes
|
|
Age, Categorical
Between 18 and 65 years
|
18 Eyes
n=18 Eyes
|
20 Eyes
n=20 Eyes
|
18 Eyes
n=18 Eyes
|
20 Eyes
n=20 Eyes
|
76 Eyes
n=76 Eyes
|
|
Age, Categorical
>=65 years
|
0 Eyes
n=18 Eyes
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=18 Eyes
|
0 Eyes
n=20 Eyes
|
0 Eyes
n=76 Eyes
|
|
Sex: Female, Male
Female
|
11 Eyes
n=18 Eyes
|
10 Eyes
n=20 Eyes
|
11 Eyes
n=18 Eyes
|
10 Eyes
n=20 Eyes
|
42 Eyes
n=76 Eyes
|
|
Sex: Female, Male
Male
|
7 Eyes
n=18 Eyes
|
10 Eyes
n=20 Eyes
|
7 Eyes
n=18 Eyes
|
10 Eyes
n=20 Eyes
|
34 Eyes
n=76 Eyes
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 Eyes
n=18 Eyes
|
20 Eyes
n=20 Eyes
|
18 Eyes
n=18 Eyes
|
20 Eyes
n=20 Eyes
|
76 Eyes
n=76 Eyes
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Twelve month data was not collected for any participants. Because of the bias in who qualified for the study it became apparent we would not get any statistically valid results.
Uncorrected visual acuity will be tested pre-operatively through month 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Per 2018 protocol amendment contrast sensitivity assessment was removed from the study procedures and thus data was not collected.
Contrast sensitivity will be tested pre-operatively and 3 months post-operatively
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: The Quality of Life Impact of Refractive Correction survey was removed from the protocol with the 2018 amendment, thus this data was not collected.
The validated Quality of Life Impact of Refractive Correction survey will be administered pre-operatively and 3 months post surgery
Outcome measures
Outcome data not reported
Adverse Events
Wavefront Optimized LASIK
Wavefront Optimized Photorefractive Keratectomy
Topography-guided LASIK
Topography-guided Photorefractive Keratectomy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mark Mifflin, MD
University of Utah John A. Moran Eye Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place