Trial Outcomes & Findings for Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus (NCT NCT03560609)
NCT ID: NCT03560609
Last Updated: 2025-01-29
Results Overview
Determination of tissue deformation will be obtained from OCT images.
TERMINATED
NA
3 participants
1 Day
2025-01-29
Participant Flow
This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. 3 participants were enrolled in the study; none of these participants were assessed for outcome measures. No participants (n=0) were enrolled into the "Subjects with Glaucoma" arm.
Participant milestones
| Measure |
Subjects With Keratoconus
Individuals with keratoconus.
|
Subjects With Glaucoma
Individuals with glaucoma.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Subjects With Keratoconus
Individuals with keratoconus.
|
Subjects With Glaucoma
Individuals with glaucoma.
|
|---|---|---|
|
Overall Study
Study terminated due to departure of Principal Investigator from Sponsoring institution
|
3
|
0
|
Baseline Characteristics
Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus
Baseline characteristics by cohort
| Measure |
Subjects With Keratoconus
n=3 Participants
Individuals with keratoconus.
|
Subjects With Glaucoma
Individuals with glaucoma.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.66 years
STANDARD_DEVIATION 4.714 • n=99 Participants
|
—
|
38.66 years
STANDARD_DEVIATION 4.714 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Determination of tissue deformation will be obtained from OCT images.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Determination of tissue deformation will be obtained from OCT images.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 DayPopulation: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure.
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Outcome measures
Outcome data not reported
Adverse Events
Subjects With Keratoconus
Subjects With Glaucoma
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