Trial Outcomes & Findings for Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain (NCT NCT01592643)
NCT ID: NCT01592643
Last Updated: 2021-12-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Day 30
Results posted on
2021-12-22
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Eye Shield
Participants receive eye shield during PRK surgery
Eye Shield: The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
|
|---|---|
|
Overall Study
STARTED
|
30 45
|
|
Overall Study
COMPLETED
|
30 45
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Photorefractive Keratectomy (PRK) Use of an Eye Shield for Maintaining Vision and Mitigating Pain
Baseline characteristics by cohort
| Measure |
Eye Shield
n=45 Eyes
Participants receive eye shield during PRK surgery
|
|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30Outcome measures
| Measure |
Eye Shield
n=30 Participants
Participants receive eye shield during PRK surgery
|
|---|---|
|
Number of Participants With Pain Score of Four or Greater. Score Range: 0-10, Higher Score Corresponds to More Pain.
|
0 Participants
|
SECONDARY outcome
Timeframe: Six monthsLogMAR uncorrected visual acuity. Values closer to zero indicate improved vision
Outcome measures
| Measure |
Eye Shield
n=45 Eyes
Participants receive eye shield during PRK surgery
|
|---|---|
|
Mean Change in Uncorrected Visual Acuity
Baseline
|
1.34 logMAR
Standard Deviation 0.55
|
|
Mean Change in Uncorrected Visual Acuity
Month six
|
-0.06 logMAR
Standard Deviation 0.11
|
Adverse Events
Eye Shield
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place