Vision Therapy for Lazy Eye
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: State University of New York College of Optometry
Disqualifiers: Preterm birth, Neurologic, Developmental, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial investigates how patching and foveation therapy can improve vision in children with amblyopia. Patching involves covering the stronger eye to strengthen the weaker one. Foveation therapy helps the weaker eye focus better. The goal is to see if these treatments can enhance visual clarity and coordination.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Vision Therapy for Lazy Eye treatment?
Research shows that using interactive games and video clips in a novel binocular treatment can improve vision in children with lazy eye, offering a promising alternative to traditional patching, which often has low compliance. Additionally, combining stereoscopic 3D video movies with part-time patching has been effective in older children who do not respond well to patching alone.
12345Is vision therapy for lazy eye safe for humans?
Vision therapy for lazy eye, including treatments like eye patching, has been studied in various clinical trials and is generally considered safe for humans. These treatments are commonly used in children and have been part of traditional approaches to improve vision in conditions like amblyopia (lazy eye).
12367How is the Vision Therapy for Lazy Eye treatment different from other treatments?
The Vision Therapy for Lazy Eye treatment is unique because it combines after-image and MIT Trainer techniques with traditional eye patching, offering a more interactive and potentially engaging approach compared to standard patching alone, which often suffers from poor compliance.
128910Eligibility Criteria
This trial is for children aged 4-16 with 'lazy eye' due to refractive issues like anisometropia, strabismus, or both. They must have a certain level of reduced vision in the affected eye and not have been born prematurely or have neurological conditions that could affect their eyes.Inclusion Criteria
Your eyes have a big difference in vision prescription between each other.
I have strabismus with a deviation of 10 or more, or it's well-aligned after surgery.
I am between 4-12 years old and prescribed patching for strabismic amblyopia.
+4 more
Exclusion Criteria
I was born prematurely, before 32 weeks of pregnancy.
I have a health condition known to affect the eyes.
I have a condition affecting the central part of my retina.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo patching treatment and foveation therapy
12 weeks
1 visit (in-person) at 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests how well different treatments work for lazy eye in kids. Some will use an eye patch while others will try visual exercises like After-image and MIT trainer to improve their vision and how they fixate on objects.
2Treatment groups
Experimental Treatment
Group I: foveation therapyExperimental Treatment1 Intervention
After-image foveation therapy training is 10 mins; MIT training is 5 minutes.
Group II: Patching groupExperimental Treatment1 Intervention
part-time patching following PEDIG guidelines.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
SUNY College of OptometryNew York, NY
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Who Is Running the Clinical Trial?
State University of New York College of OptometryLead Sponsor
References
An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. [2023]Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching.
Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial. [2021]Amblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatment consists of wearing a patch over their 'good' eye for a number of hours daily, over several months. This treatment is unpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3D technology to present specially developed computer games and video footage (I-BiT™) has been studied in a small group of patients and has shown positive results over a short period of time. The system is therefore now being examined in a randomised clinical trial.
Comparison between over-glasses patching and adhesive patching for children with moderate amblyopia: a prospective randomized clinical trial. [2018]To investigate efficacy of over-glasses patching treatment for amblyopic children using visual function improvement and Amblyopia Treatment Index (ATI) changes.
Elbow splinting as a method to increase patching compliance in amblyopia therapy. [2018]PurposeThe purpose of the study was to evaluate the feasibility and acceptability of utilizing elbow splints as a method of increasing amblyopic patching compliance in pediatric ophthalmology patients who fail to comply with prescribed patching regimens.Patients and methodsPatients
Effectiveness of binocular therapy as a complementary treatment of part-time patching in older amblyopic children: a randomized clinical trial. [2023]To assess the effectiveness of combined use of stereoscopic 3D video movies and part-time patching in treating older amblyopic children with poor response or compliance to traditional patching treatments and comparing this combined treatment with patching alone.
Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. [2022]To evaluate the factors associated with the efficacy of low-dose part-time patching in children with intermittent exotropia (IXT).
Comparison of the effectiveness of amblyopia treatment with eye-patch and binocular Occlu-tab for the same treatment duration. [2023]This study aimed to compare the conventional eye patch with Occlu-tab-a binocular open-type amblyopia training device-and evaluate their effectiveness in amblyopia treatment.
Amblyopia: out of the dark, into the light. [2021]For over a hundred years, patching of the good eye has been the main and often only method of treating a 'lazy' or amblyopic eye. A recent study shows that a period of time in complete darkness can promote rapid recovery of vision.
Impact of active vision therapy compared to conventional patching therapy on visual acuity and stereoacuity in children with amblyopia. [2023]To compare improvements in visual acuity (VA) and stereoacuity between active vision therapy (AVT) and conventional patching therapy in children with amblyopia.
Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial. [2020]Amblyopia ("lazy eye") is the commonest vision deficit in children. If not fully corrected by glasses, amblyopia is treated by patching or blurring the better-seeing eye. Compliance with patching is often poor. Computer-based activities are increasingly topical, both as an adjunct to standard treatment and as a platform for novel treatments. Acceptability by families has not been explored, and feasibility of a randomised controlled trial (RCT) using computer games in terms of recruitment and treatment acceptability is uncertain.