Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision

Not Applicable

Terminated

• Conditions: CLN3-related Disorders; Non-CLN3 Related Low Vision
• Interventions: Device: OrCam MyEye 2

• Registration Number: NCT04974307
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Detailed Description

Study Description:

This is a pilot study of an augmentative visual device, OrCam MyEye 2 (OrCam), in pediatric individuals with CLN3-related conditions or low vision. We hypothesize that, given the relatively simple design and operating procedure of the device, the use of the OrCam by study participants will be safe and feasible. We also hypothesize that the device will enhance their ability to obtain visually based information.

Objectives:

Primary: Assess the safety and feasibility of OrCam use by children with CLN3 or low vision.

Endpoints:

Primary:

1. Adverse events during the use of OrCam

2. Feasibility test

3. Feasibility questionnaire

The assessment periods will be 1 week at study site.

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-23
• Study Start: 2021-09-30
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-07
• Status Verified: 2024-02
• Results First Submitted: 2024-10-01
• Results First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Results First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	OrCam MyEye 2	use of OrCam MyEye 2.0

Primary Outcome Measures

Name	Time	Method
Participants With Adverse Events	1 week	Number of participants with adverse events related to the use of OrCam MyEye 2. Adverse events were collected from parental report.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States