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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 1 month
Awards & highlights

Study Summary

This trial will test if the OrCam, an assistive device, is safe and useful for children with CLN3 or blindness.

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.Check my eligibility
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.See study design
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 below
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My best eye sees worse than 20/200 without help.
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I am between 6 and 18 years old.
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I have or might have a genetic condition causing significant vision loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 1 month for reporting.

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

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,963 Previous Clinical Trials
2,674,730 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

Media Library

OrCam MyEye 2 Clinical Trial Eligibility Overview. Trial Name: NCT04974307 — N/A
Batten Disease Research Study Groups: Device
Batten Disease Clinical Trial 2023: OrCam MyEye 2 Highlights & Side Effects. Trial Name: NCT04974307 — N/A
OrCam MyEye 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04974307 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is allowed to participate in this research initiative?

"In order to enter this trial, applicants must possess proper visual acuity and be between 6-18 years old. Currently, the research is looking for 50 participants in total."

Answered by AI

What is the cap on patient enrollment for this clinical investigation?

"That is correct. According to the details posted on clinicaltrials.gov, this study started recruiting in September 2021 and has been actively searching for participants since then. The trial intends to enroll 50 patients at one site."

Answered by AI

Are there opportunities for participants to join this experiment?

"The trial's information on clinicaltrials.gov affirms that the study is actively enrolling participants. The medical research project was initially posted on September 30th 2021 and its details were last revised on November 5th 2022."

Answered by AI

Does this trial encompass adults aged thirty and over?

"The age requirement for this trial is between 6 and 18 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
2021. "Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04974307.
~3 spots leftby Apr 2025
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