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NCT04974307 · ClinicalTrials.gov registry record · NA
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
A NA study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04974307: Clinical Trial NA study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT04974307 is a NA study that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04974307, a NA study, was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Background: 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 with non-CLN3 related blindness. Objective: To learn if it is safe, easy, and useful for children with CLN3 or with non-CLN3 related blindness to use the OrCam. Eligibility: People aged 6-18 years who have either CLN3-related disease or non-CLN3 related blindness. Design: Participants will be screened with the following: Medical history Physical exam Family history 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. Blood samples 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.
Primary Outcome
Number of participants with adverse events related to the use of OrCam MyEye 2. Adverse events were collected from parental report.
Interventions
- DEVICE OrCam MyEye 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2023-10-07 |
| Phase | NA |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Why NCT04974307 stopped before completion
NCT04974307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which OrCam MyEye 2 is the first listed.
NCT04974307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04974307 about?
NCT04974307 is a clinical study titled "Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision". Background: 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 with non-CLN3 related blindness. Objective: To learn if it is safe, easy, and useful...
What is the current status of trial NCT04974307?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2021-09-30. Estimated completion is 2023-10-07.
What interventions are being tested in trial NCT04974307?
The interventions under investigation include: OrCam MyEye 2 (DEVICE).
Who is sponsoring clinical trial NCT04974307?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04974307's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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