Trial Outcomes & Findings for Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus (NCT NCT03647046)
NCT ID: NCT03647046
Last Updated: 2020-03-31
Results Overview
Vision will be tested using the Basic Snellen Visual Acuity test and normal vision will be defined as 20/20.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
30 minutes
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Customized Scleral Lens
A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.
Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus
Baseline characteristics by cohort
| Measure |
Customized Scleral Lens
n=12 Participants
A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.
Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Keratoconus
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesVision will be tested using the Basic Snellen Visual Acuity test and normal vision will be defined as 20/20.
Outcome measures
| Measure |
Customized Scleral Lens
n=8 Participants
A customized scleral lens will be compared with a non-customized scleral lens in subjects with Keratoconus through vision tests.
Customized Scleral Lens: A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.
|
|---|---|
|
Number of Participants With Normal Vision
|
8 Participants
|
Adverse Events
Customized Scleral Lens
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