Asynchronous Movies for Amblyopia

R

Retina Foundation of the Southwest

Status

Enrolling

Conditions

Amblyopia

Treatments

Device: Patching
Device: Asynchronous 3D movies

Study type

Interventional

Funder types

Other

Identifiers

NCT05439200
RFSW113B

Details and patient eligibility

About

The purpose of this study is to determine whether viewing asynchronous movies 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 treatment.

Full description

This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. 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 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 and 4 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks. The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, 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 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).

Enrollment

44 estimated patients

Sex

All

Ages

3 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • aged 3-8 years (3-7 primary cohort)
  • male and female
  • strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
  • interocular visual acuity difference ≥0.3 logMAR
  • wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
  • child's ophthalmologist and family willing to forgo standard patching treatment during the study

Exclusion criteria

  • prematurity ≥8 wk
  • coexisting ocular or systemic disease
  • developmental delay
  • strabismus >5 pd
  • myopia > -3.00D

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Asynchronous movies
Experimental group
Description:
Asynchronous 3D movies
Treatment:
Device: Asynchronous 3D movies
Standard-of-care patching with an adhesive patch
Active Comparator group
Description:
Standard-of-care patching with an adhesive patch
Treatment:
Device: Patching

Trial contacts and locations

1

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Central trial contact

Eileen E Birch, PhD; Reed M Jost, MS

Data sourced from clinicaltrials.gov

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