Patch-free Occlusion Therapy

Amblyopia Clinical Trial

Official title:

Patch-free Occlusion Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440448
• Other study ID #: RFSW113A
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• 3-10 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

• myopia > -3.00D

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Patch-free occlusion therapy
Use of filters in glasses to provide occlusion therapy
• Adhesive patch
Standard-of-care occlusion therapy with an adhesive patch

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 measured with a logMAR visual acuity chart	change in logMAR relative to baseline	12 weeks
Secondary	Change in amblyopic eye visual acuity measured with a logMAR visual acuity chart	change in logMAR relative to baseline	6,18, and 24 weeks
Secondary	Adherence to patching or viewing videos with glasses measured with a sensor	cumulative hours of treatment with the patch or glasses used to watch videos objectively monitored with the skin temperature sensitive Theramon sensor	6 and 12 weeks
Secondary	Proportion of children who have recovered	Proportion of children who attain amblyopic eye visual acuity of 0.1 logMAR or better	6 and 12 weeks
Secondary	Change in extent of suppression assessed with W4 test	changes in log deg measure with W4 test	6 and 12 weeks
Secondary	change in stereoacuity assessed with the Randot Preschool Stereoacuity Test	change in log arcsec	6 and 12 weeks
Secondary	Change in motor skills assessed with the Movement Assessment Battery for Children-2	change in Movement Assessment Battery for Children-2 (MABC-2) standard scores relative to baseline (normed and scaled 0-19 for worst to best, with 10=average, 5-6 = "at risk", and <5 = "significant impairment")	12 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)	12 weeks
Secondary	Improvement in quality of life assesses 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)	12 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 and 12 weeks