Asynchronous Movies for Amblyopia

Amblyopia Clinical Trial

Official title:

Asynchronous Movies for Amblyopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439200
• Other study ID #: RFSW113B
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2023
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Retina Foundation of the Southwest
• Contact: Eileen E Birch, PhD
• Phone: 2143633911
• Email: ebirch[@]retinafoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Asynchronous 3D movies
3D movies streamed at home for viewing on a handheld lenticular 3D screen
• Patching
Adhesive patch to cover the fellow eye

Locations

Country	Name	City	State
United States	Retina Foundation	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Retina Foundation of the Southwest

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in amblyopic eye visual acuity using a logMAR chart	change in amblyopic eye logMAR visual acuity relative to baseline	6 weeks
Secondary	Change in amblyopic eye visual acuity using a logMAR chart	change in amblyopic eye logMAR visual acuity relative to baseline at 2, 4, 8, and 10 weeks	2, 4, 8, and 10 weeks
Secondary	Change in extent suppression assessed with the W4 test	change in log deg assessed with the W4 test relative to baseline	6 weeks
Secondary	Change in stereoacuity assessed with the Randot Preschool Stereoacuity Test	change in log arcsec in stereoacuity assessed with the Randot Preschool Stereoacuity Test	6 weeks
Secondary	Change in motor skills assessed with the Movement Assessment Battery for Children -2	change in standard scores obtained with the Movement Assessment Battery for Children -2 (MABC-2; (normed and scaled 0-19, with 10 as an average score, 5-6 as "at risk", and <5 as "significant impairment")	6 weeks
Secondary	Change in self perception assessed with the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children	change in domain scores of the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (standard scores scaled to range from 0 to 100 for worst to best)	6 weeks
Secondary	Change in quality of life assessed with the Pediatric Eye Questionnaire	change in domain scores of the Pediatric Eye Questionnaire (PedEyeQ; Rasch calibrated and scaled to score from 0 to 100 for worst to best)	6 weeks
Secondary	Proportion of children who have recovered	proportion of children who attain amblyopic eye visual acuity of at least 0.1 logMAR	2, 4, 6, 8, and 10 weeks
Secondary	Adherence to patching measured with a sensor and adherence to viewing videos measured with the streaming log data	cumulative hours of treatment with the patch objectively monitored temperature sensitive Theramon sensor or with movie viewing by monitoring the streaming logs	2,4, and 6 weeks
Secondary	Change in depth of suppression assessed with the contrast balance index	change in contrast balance index (ratio of amblyopic eye to fellow eye contrast needed to overcome suppression	6 weeks