Clinical Trials Logo

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


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

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
Recruiting NCT06429280 - Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
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
Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1