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Optic-to-Audio Device for Low Vision
N/A
Waitlist Available
Led By An N Dang Do, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has an estimated visual acuity in the better seeing eye < 20/200, without the use of an assistive or augmentative device
Is between 6 to 18 years of age
Must not have
Has any of the following auditory dysfunctions: non-reversible or non-correctable hearing loss, tinnitus that is chronic or occurring daily, auditory hallucinations that occur daily
Is unable to travel to the NIH because of medical condition for required in-person portions of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 1 month
Awards & highlights
Summary
This trial tests the OrCam MyEye 2, a small device that attaches to glasses and helps people with vision problems by reading text and recognizing faces and objects. It targets children aged 6-18 who have CLN3-related disease or blindness. The device works by using a camera to capture visual information and then providing audio descriptions to the user. Researchers aim to see if it is safe, easy to use, and effective for these children.
Who is the study for?
This trial is for children aged 6-18 with CLN3-related disease or severe vision loss, having visual acuity less than 20/200. They should have cognitive abilities to participate and not use similar devices recently. Those with certain hearing issues, travel restrictions due to health, or conditions increasing study risks are excluded.
What is being tested?
The OrCam MyEye 2 device is being tested on kids with CLN3 or low vision to see if it's safe and helpful. It's a small device that attaches to glasses and helps the visually impaired by converting visual information into audio cues.
What are the potential side effects?
Since the OrCam MyEye 2 is a non-invasive assistive device, there may be minimal side effects related mainly to comfort of wearing the device or potential psychological impact from dependency on technology for assistance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My best eye sees worse than 20/200 without help.
Select...
I am between 6 and 18 years old.
Select...
I have or might have a genetic condition causing significant vision loss.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience daily tinnitus, hearing loss that can't be corrected, or daily auditory hallucinations.
Select...
I cannot travel to NIH for the study due to my health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess: a) safety and b) feasibility of using OrCam MyEye 2 by children with CLN3 or low vision
Secondary outcome measures
To assess the efficacy of using the OrCam by children with CLN3 or low vision
Trial Design
1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
use of OrCam MyEye 2.0
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OrCam MyEye 2
2021
N/A
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Batten Disease, particularly CLN3-related conditions, leads to progressive vision loss and eventual blindness. The OrCam device, an assistive technology, is being studied for its potential to aid children with CLN3 or blindness by converting visual information into audio cues.
This mechanism of action is crucial as it provides an alternative sensory input to compensate for the loss of vision, thereby enhancing the patient's ability to interact with their environment and maintain a degree of independence. The emphasis on visual and auditory assistance in treatments like OrCam is significant because it directly addresses the sensory deficits caused by Batten Disease, potentially improving the quality of life for patients.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,988 Previous Clinical Trials
2,683,512 Total Patients Enrolled
An N Dang Do, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 Previous Clinical Trials
578 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot travel to NIH for the study due to my health condition.I have CLN3 disease confirmed by genetic testing or specific clinical signs.My best eye sees worse than 20/200 without help.I experience daily tinnitus, hearing loss that can't be corrected, or daily auditory hallucinations.I am between 6 and 18 years old.You use a device that helps you hear instead of see, and you have been using it within the past 3 months.I have or might have a genetic condition causing significant vision loss.I can understand and participate in the trial as assessed by the investigator.
Research Study Groups:
This trial has the following groups:- Group 1: Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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