Patch-free Occlusion Therapy

Status Recruiting

Clinical Trial Summary

The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.

Clinical Trial Description

This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch. Children will participate in their assigned occlusion therapy at home for 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks. The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% CIs). ;

Study Design

Related Conditions & MeSH terms

Amblyopia

Clinical Trial Details

NCT number	NCT05440448
Study type	Interventional
Source	Retina Foundation of the Southwest
Contact	Eileen E Birch, PhD
Phone	2143633911
Email	ebirch@retinafoundation.org
Status	Recruiting
Phase	N/A
Start date	June 12, 2023
Completion date	December 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04238065` - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia	N/A
Completed	`NCT04432181` - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Terminated	`NCT02767856` - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children	N/A
Completed	`NCT02458846` - Efficacy of Visual Screening in Ontario	N/A
Completed	`NCT01190813` - Levodopa for the Treatment of Residual Amblyopia	Phase 3
Completed	`NCT01109459` - Multimodal Physician Intervention to Detect Amblyopia	N/A
Completed	`NCT04313257` - Monocular Action Video Game Treatment of Amblyopia	N/A
Completed	`NCT04315649` - Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops	N/A
Completed	`NCT05223153` - OCT-A and Amblyopia
Recruiting	`NCT05522972` - Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games	N/A
Completed	`NCT01430247` - Vision Screening for the Detection of Amblyopia	N/A
Completed	`NCT02200211` - Study of Binocular Computer Activities for Treatment of Amblyopia	N/A
Withdrawn	`NCT04959422` - Assuring Ophthalmologic Follow up	N/A
Active, not recruiting	`NCT05612568` - 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Recruiting	`NCT03655912` - Binocular Visual Therapy and Video Games for Amblyopia Treatment.	N/A
Recruiting	`NCT06150391` - Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program	N/A
Completed	`NCT03754153` - Binocularly Balanced Viewing Study	N/A
Terminated	`NCT02246556` - Dichoptic Virtual Reality Therapy for Amblyopia in Adults	Phase 1
Withdrawn	`NCT02594358` - Caffeine in Amblyopia Study	Phase 1/Phase 2
Completed	`NCT02003235` - Assessment of Device for Treatment of Amblyopia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.