Curesight Videos for Lazy Eye
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an at-home treatment called Curesight™, designed to help children with amblyopia, commonly known as "lazy eye." This treatment uniquely allows children to watch their favorite videos while strengthening their weaker eye. The trial targets children aged 8 to 12 who have stopped using other amblyopia treatments. It offers an opportunity for those with vision differences between their eyes who have worn glasses for at least eight weeks. The goal is to determine if Curesight™ can improve vision in this age group. As an unphased trial, it provides a unique chance for children to try an innovative treatment that could enhance their vision while they enjoy their favorite activities.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you must not be using standard-of-care treatments for amblyopia to participate.
What prior data suggests that Curesight™ is safe for children aged 8 to 12 years?
Research has shown that CureSight™ is a safe treatment for children with lazy eye, also known as amblyopia. Earlier studies tested the treatment on children aged 4 to 9 years, and it was well-tolerated. The FDA has approved CureSight™ to improve vision in these age groups, confirming it meets safety standards for children. Although the current study targets slightly older children, no specific evidence indicates safety issues for them. So far, younger children treated with CureSight™ have not reported major side effects.12345
Why are researchers excited about this trial?
Researchers are excited about Curesight™ videos for treating lazy eye, or amblyopia, because this method offers a novel approach that differs from traditional treatments like eye patches or atropine drops. Unlike these common methods that often focus on blocking or blurring vision in the stronger eye to force the weaker one to work harder, Curesight™ involves engaging videos that are designed to improve visual and stereo acuity directly. This innovative approach not only makes the treatment more engaging and potentially more enjoyable for children, but it also addresses the condition by stimulating the weaker eye in a way that is less invasive and more interactive.
What evidence suggests that Curesight™ might be an effective treatment for lazy eye in children aged 8 to 12?
Research has shown that Curesight™ effectively treats amblyopia, commonly known as "lazy eye." In a study with 103 young patients, Curesight™ improved vision more effectively than traditional eye patching. The FDA has approved this treatment for children as young as 4 years old. While most studies have focused on children aged 4 to 8, this trial explores whether these benefits also apply to those aged 8 to 12. Given its success in younger children, there is hope it could also benefit older kids.1267
Are You a Good Fit for This Trial?
This trial is for children aged 8 to 12 with lazy eye (amblyopia). Participants must have access to a computer at home for treatment. The study excludes those who don't meet the age requirement or have other eye conditions that could interfere with the treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive at-home amblyopia treatment with Curesight™ for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Curesight™
Trial Overview
The Curesight™ system is being tested, which streams videos on a computer screen. It's designed so the amblyopic eye sees clearly while blurring part of the image for the other eye, aiming to improve vision in the lazy eye.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
with this IRB application), indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4 - \<9 years, associated with anisometropia and/or with mild strabismus. This approval was based on data from a pilot study and a multi-center randomized clinical trial conducted with children aged 4 to 8 years.25,26 However, very few children older than age 7 years were included so the effectiveness of Curesight™ treatment for children aged 8 to 12 is unknown. Our pilot study will evaluate response to the Curesight™ treatment in this older age range.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Retina Foundation of the Southwest
Lead Sponsor
Citations
CureSight amblyopia treatment
The trial, which included 103 patients, compared the improvement in visual outcomes achieved by CureSight versus the eye patch. This is the first ever ...
Amblyopia Treatment for Children Aged 8 to 12 Years
This study is being done to assess the effect of at-home amblyopia treatment with Curesight™ for children aged 8 to 12 years.
Cost-effectiveness Analysis of Digital Therapeutics for ...
This study evaluated the cost utility of the two Food and Drug Administration-cleared digital therapies, Luminopia and CureSight, for treatment of amblyopia.
4.
ophthalmologytimes.com
ophthalmologytimes.com/view/novasight-releases-successful-results-of-amblyopia-treatment-trialNovaSight releases successful results of amblyopia ...
The study, which randomly assigned 103 patients from the ages of 4 to 9, compared the improvement in visual outcomes achieved by CureSight ...
K221375 - Lee Kramm - accessdata.fda.gov
The CureSight™ system is indicated for improvement in visual acuity and stereo acuity in amblyopia patients, aged 4-<9 years, associated with ...
CureSight-brochure-separated-pages.pdf
CureSight™ is an eye tracking based system designed for remote binocular vision treatment in pediatric patients (aged. 4 to 9 years) suffering from amblyopia.
CureSightŘE TUNİ - FREQUENTLY USED
CureSight™ is an FDA cleared eye tracking based system designed for remote ... the amblyopic eye receives a normal, sharp video stream. The CureSight ...
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