Trial Outcomes & Findings for Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision (NCT NCT04974307)
NCT ID: NCT04974307
Last Updated: 2024-10-23
Results Overview
Number of participants with adverse events related to the use of OrCam MyEye 2. Adverse events were collected from parental report.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1 week
Results posted on
2024-10-23
Participant Flow
Of 11 participants consented for the study, one participant was a screen failure
Participant milestones
| Measure |
Children With CLN3 Disease
Children with CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
Children With Low Vision Without CLN3
Children with low vision not related to CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
1
|
|
Overall Study
COMPLETED
|
9
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Baseline characteristics by cohort
| Measure |
Children With CLN3 Disease
n=9 Participants
Children with CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
Children With Low Vision Without CLN3
n=1 Participants
Children with low vision not related to CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
1 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: All participants who completed week one of the study.
Number of participants with adverse events related to the use of OrCam MyEye 2. Adverse events were collected from parental report.
Outcome measures
| Measure |
Children With CLN3 Disease
n=9 Participants
Children with CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
Children With Low Vision Without CLN3
n=1 Participants
Children with low vision not related to CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
|---|---|---|
|
Participants With Adverse Events
|
1 Participants
|
0 Participants
|
Adverse Events
Children With CLN3 Disease
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Children With Low Vision Without CLN3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Children With CLN3 Disease
n=9 participants at risk
Children with CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
Children With Low Vision Without CLN3
n=1 participants at risk
Children with low vision not related to CLN3 use the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs for text reading, facial recognition, and product identification. The study participants and parents/guardians were trained on how to use the device.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • One week and up to one month depending on length of participation in study
|
0.00%
0/1 • One week and up to one month depending on length of participation in study
|
Additional Information
Dr. An Ngoc Dang Do
National Institute of Child Health and Human Development (NICHD)
Phone: 301-496-8849
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place