Trial Outcomes & Findings for Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure (NCT NCT03286426)

NCT ID: NCT03286426

Last Updated: 2022-02-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
• Results posted on: 2022-02-15

Participant Flow

Participant milestones

Measure	Vision/Eye Screening Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Vision/Eye Screening Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
Overall Study Physician Decision	3

Baseline Characteristics

Ocular Screening in Children and Young Adults at Risk for Increased Intracranial Pressure

Baseline characteristics by cohort

Measure	Vision/Eye Screening n=3 Participants Image of back of each eye along with color vision and visual acuity assessment if able. Vision/Eye screening: The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
Age, Categorical <=18 years	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	59 months STANDARD_DEVIATION 75 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	2 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	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Population: Data not collected as only one visit occurred and a change could not be measured.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Population: Data not collected as only one visit occurred and a change could not be measured.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent

Population: Data not collected as only one visit occurred and a change could not be measured.

Outcome measures

Outcome data not reported

Adverse Events

Vision/Eye Screening

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

Dr. Grace Prakalapakorn

Duke Eye Center

Phone: +1 919 684 7679

Email: grace.prakalapakorn@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place