Trial Outcomes & Findings for Evaluating and Improving Functional Driving Vision of Patients With Astigmatism (NCT NCT02624791)
NCT ID: NCT02624791
Last Updated: 2020-03-06
Results Overview
Z-score composite of tactical testing outcomes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1 day laboratory study
Results posted on
2020-03-06
Participant Flow
Participant milestones
| Measure |
Lens Sequence 1
None; Sphere; Toric
|
Lens Sequence 2
None; Toric; Sphere
|
Lens Sequence 3
Sphere; None; Toric
|
Lens Sequence 4
Sphere; Toric; None
|
Lens Sequence 5
Toric; None; Sphere
|
Lens Sequence 6
Toric; Sphere; None
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
2
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lens Sequence 1
None; Sphere; Toric
|
Lens Sequence 2
None; Toric; Sphere
|
Lens Sequence 3
Sphere; None; Toric
|
Lens Sequence 4
Sphere; Toric; None
|
Lens Sequence 5
Toric; None; Sphere
|
Lens Sequence 6
Toric; Sphere; None
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluating and Improving Functional Driving Vision of Patients With Astigmatism
Baseline characteristics by cohort
| Measure |
Contact Lens Sequence
n=11 Participants
Order in which each participant received the 3 lens conditions
|
|---|---|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 4.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day laboratory studyZ-score composite of tactical testing outcomes
Outcome measures
| Measure |
Contact Lens Rx
n=9 Participants
All study participants
|
|---|---|
|
Tactical Composite Score
None
|
-1.73 Z score
Standard Deviation 3.53
|
|
Tactical Composite Score
Sphere
|
0.19 Z score
Standard Deviation 2.62
|
|
Tactical Composite Score
Toric
|
1.54 Z score
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 1 day laboratory studyZ-score composite of operational testing outcomes
Outcome measures
| Measure |
Contact Lens Rx
n=11 Participants
All study participants
|
|---|---|
|
Operational Composite Score
None
|
-2.77 Z score
Standard Deviation 4.30
|
|
Operational Composite Score
Sphere
|
1.37 Z score
Standard Deviation 2.37
|
|
Operational Composite Score
Toric
|
1.40 Z score
Standard Deviation 2.65
|
Adverse Events
Contact Lens Rx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Project Coordinator
UVa Center for Behavioral Medicine Research
Phone: 434-924-8656
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place