Trial Outcomes & Findings for Performance and Acceptability of VSS-R (NCT NCT01067716)
NCT ID: NCT01067716
Last Updated: 2013-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
1 Year
Results posted on
2013-10-31
Participant Flow
One or both eyes of 79 subjects (150 eyes) were treated.
Participant milestones
| Measure |
Myopia With and Without Astigmatism
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
13
|
9
|
|
Overall Study
COMPLETED
|
57
|
13
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Performance and Acceptability of VSS-R
Baseline characteristics by cohort
| Measure |
Myopia With or Without Astigmatism
n=57 Participants
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=13 Participants
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=9 Participants
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
57 participants
n=5 Participants
|
13 participants
n=7 Participants
|
9 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: As a measure of effectiveness of LASIK treatment with VSS, distance visual performance without spectacles, clinically measured as Uncorrected Visual Acuity (UCVA) will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=57 Participants
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=25 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=15 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percent of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
|
99.1 percentage of eyes
Interval 95.0 to 100.0
|
96.0 percentage of eyes
Interval 79.6 to 99.9
|
100.0 percentage of eyes
Interval 81.9 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearPopulation: As a measure of effectiveness of LASIK treatment with VSS, the required spectacle prescription, also called manifest refraction, will be measured under standardized conditions such as 4 meter testing distance, controlled ambient room lighting and standard eye charts.
Manifest refraction spherical equivalent is the required spectacle (or glass) prescription.
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=110 eyes
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=25 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=15 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Percent Manifest Refraction Spherical Equivalent Within 1.0D
|
96.4 percentage of eyes
Interval 91.0 to 99.0
|
92.0 percentage of eyes
Interval 74.0 to 99.0
|
100.0 percentage of eyes
Interval 81.9 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearAfter surgery, with or without best spectacle prescription the subject is not expected to see worse than before surgery. As a metric for this safety endpoint, losses of 2 lines of vision on a standard eye chart, with best spectacle correction, after surgery compared to pre-operative baseline shall be evaluated. For example 20/20 is typically considered best vision and 2 lines worse than this will be 20/32).
Outcome measures
| Measure |
Myopia With and Without Astigmatism
n=110 eyes
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=25 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=15 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
|
.9 percentage of eyes
Interval 0.0 to 5.0
|
4.0 percentage of eyes
Interval 0.1 to 20.4
|
0.0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had a loss of more than 2 lines of BSCVA
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 YearOutcome measures
| Measure |
Myopia With and Without Astigmatism
n=110 eyes
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=25 eyes
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=15 eyes
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Induced Manifest Refractive Astigmatism Greater Than 2.0 D of Absolute Cylinder Power
|
0.0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.0 D of absolute cylinder power.
|
0.0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.0 D of absolute cylinder power.
|
0.0 percentage of eyes
Confidence intervals were not calculated because 0% of eyes had induced manifest refractive astigmatism greater than 2.0 D of absolute cylinder power.
|
Adverse Events
Myopia With or Without Astigmatism
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Hyperopia With and Without Astigmatism
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Mixed Astigmatism
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Myopia With or Without Astigmatism
n=57 participants at risk
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=13 participants at risk
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=9 participants at risk
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Eye disorders
Decrease in BSCVA of greater than or equal to two lines
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
Other adverse events
| Measure |
Myopia With or Without Astigmatism
n=57 participants at risk
Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
|
Hyperopia With and Without Astigmatism
n=13 participants at risk
Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
|
Mixed Astigmatism
n=9 participants at risk
Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
|
|---|---|---|---|
|
Eye disorders
Inadvertent insallation of Tropicamide instead of Tetracaine
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Elevated IOP (temporary)
|
3.5%
2/57 • Number of events 2 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Photic phenomena (i.e., halos, glare, starbursts)
|
15.8%
9/57 • Number of events 9 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Corneal Haze
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Dry eye
|
7.0%
4/57 • Number of events 4 • 1 year
|
38.5%
5/13 • Number of events 5 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Double vision
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Superficial epithelial linear laceration
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Peripheral infiltrates
|
1.8%
1/57 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/9 • 1 year
|
|
Injury, poisoning and procedural complications
Other - hairline ankle fracture
|
0.00%
0/57 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Other - cold/flu
|
1.8%
1/57 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/9 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least ninety (90) days prior to any proposed submission for publication or presentation of Study Data or other findings related to the Study, Institution will provide Sponsor with a manuscript of such submission(s) for review, comment, and approval. For greater certainty, neither Institution nor Principal Investigator shall have any right to publish any information or results concerning the Study without the express written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER