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.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

1 Day

Results posted on

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

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

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

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=5 Participants	—	38.66 years STANDARD_DEVIATION 4.714 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: 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 Day

Determination of tissue deformation will be obtained from OCT images.