Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04974307|
Recruitment Status : Recruiting
First Posted : July 23, 2021
Last Update Posted : September 23, 2021
CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years. Researchers want to test an assistive device that may help children with CLN3 or blindness.
To learn if it is safe, easy, and useful for children with CLN3 or blindness to use the OrCam.
People aged 6-18 years who have either CLN3-related disease or blindness.
Participants will be screened with the following:
Eye exam and vision tests. They will get eyedrops to dilate their eyes.
Psychological and neurocognitive tests. They will be asked questions and observed for how they do various tasks, such as talking, playing, writing, drawing, and solving problems.
Hearing tests. They may wear headphones or earplugs. Electrodes may be taped to their head.
Skin biopsy, if needed
Cheek cell, saliva, or urine samples
The OrCam is the size of and weighs about half as much as a pack of gum. It is attached to eyeglass frames by magnets. Participants will do tasks before and after they have been trained on the OrCam. They will do these tasks without or with using the OrCam.
Participants will be given an OrCam to use for 1 week or 1 month. They will have check-in sessions with the study team.
Participants and/or their caregivers will be asked about abilities, behaviors, social skills, learning methods, intelligence, and health-related quality of life.
Participants samples may be used for genetic testing and/or to make a type of stem cell.
Participation will last for 1-5 weeks.
|Condition or disease||Intervention/treatment||Phase|
|CLN3-related Disorders Low Vision||Device: OrCam MyEye 2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Pilot Study of an Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision|
|Estimated Study Start Date :||September 28, 2021|
|Estimated Primary Completion Date :||January 20, 2025|
|Estimated Study Completion Date :||January 20, 2025|
use of OrCam MyEye 2.0
Device: OrCam MyEye 2
The study uses the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs. Its advertised functions include text reading, facial recognition, and product identification. The study participants and parents/guardians will be trained on how to use the device. Evaluations for primary and secondary endpoints will be done following 1 week and 1 month of device use.
- To assess: a) safety and b) feasibility of using OrCam MyEye 2 by children with CLN3 or low vision [ Time Frame: 1 week, 1 month ]a) Adverse events; b) Feasibility test, Feasibility questionnaire, and Device use diary
- To assess the efficacy of using the OrCam by children with CLN3 or low vision [ Time Frame: 1 week, 1 month ]1) Function Test - Efficacy Scores; 2) Ability questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974307
|Contact: An N Dang Do, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||An N Dang Do, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|