Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia.
Reed M Jost, Krista R Kelly, Eileen E Birch
https://pubmed.ncbi.nlm.nih.gov/37619861/Actively Recruiting
Led by Retina Foundation of the Southwest · Updated on 2026-02-23
120
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating enhanced binocular treatments for children aged 4 to 10 years with amblyopia, a condition that affects vision in one eye. The study compares new treatment protocols designed to extend therapy beyond the usual 4-week period to see if they result in a more complete and stable recovery of vision. This research aims to determine if these alternative methods improve visual acuity and binocular vision compared to the original treatment approach. Participants will play binocular games on a tablet for one hour per day, five days a week, using different contrast increment protocols. The study is a randomized trial with three groups the original 10% contrast increment, a reduced contrast increment, and no contrast increment. After 8 weeks, children who achieve normal visual acuity will begin stereoacuity training for 4 weeks, while those with remaining vision issues will receive dichoptic movie treatment for an additional 4 weeks. During the 12-week study, children will be assessed at various time points to measure changes in visual acuity, stereoacuity, and suppression. Visual acuity of the amblyopic eye is the primary outcome measured at baseline and 8 weeks. Participants and their families must agree to avoid patching treatments during the study. The research includes regular monitoring and requires children to be able to play the binocular games to participate.
CONDITIONS
Binocular Amblyopia Treatment
R
Reed Jost, MS
K
Krista Kelly, PhD
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Retina Foundation of the Southwest
Lead Sponsor
National Eye Institute (NEI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Binocular games with reduced contrast increment for the fellow eye | Binocular games with standard contrast increment for the fellow eye | Binocular games with no contrast increment for the fellow eye |
|---|---|---|---|
| What it is | Children play the same binocular games on a tablet, but the fellow eye is presented with a reduced contrast increment compared to standard. The session length and frequency remain the same as the other arms. | Children play binocular games on a tablet, with the fellow eye receiving a standard level of contrast increment and the amblyopic eye receiving high contrast. The gaming sessions last one hour daily, five days per week. | Children play binocular games on a tablet where the fellow eye receives no contrast increment, while the amblyopic eye still receives high contrast. Session timing and frequency are consistent across arms. |
| Role in trial | Tested as an experimental protocol to assess whether lower contrast for the fellow eye improves outcomes. | Serves as the active comparator arm representing a common contrast increment protocol for binocular amblyopia treatment. | Tested as a second experimental protocol to evaluate the effect of eliminating contrast increment for the fellow eye entirely. |
| Primary use | Aims to enhance visual outcomes in amblyopia by reducing the contrast given to the fellow eye during binocular game play. | Designed to improve visual acuity and binocular function in children with amblyopia by using standard fellow eye contrast adjustment during gaming therapy. | Seeks to determine if omitting contrast increment for the fellow eye offers a different or improved visual benefit during therapy. |
| How it is given or performed | Children follow the same regimen and schedule of tablet-based games, but with reduced contrast increment for the fellow eye. | Children use a tablet to play prescribed binocular games for 1 hour each day, 5 days per week, with specific contrast settings as assigned. | Tablet-based binocular games are played using identical daily and weekly timing, with the fellow eye set to receive no extra contrast increment. |
| Evidence status | Limited published evidence exists; the effectiveness of reduced contrast increment protocols for amblyopia is being further investigated in this and related studies. | Published data from previous randomized clinical trials show that this approach can improve vision in some children, but optimal contrast protocols continue to be studied. | This protocol is still under clinical investigation and lacks established published evidence for its use in routine care. |
| Important limitations | Uncertainty exists regarding whether reducing contrast increment offers advantages over standard settings, and there is minimal long-term follow-up data. | Visual improvements may vary by individual and long-term effectiveness compared to other protocols or standard treatments like patching remains under investigation. | Omitting contrast increment is experimental, and there is little published evidence about durability or superiority compared to established contrast-based protocols. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants play binocular games on a tablet for amblyopia treatment, 1 hour per day, 5 days per week with varying contrast protocols over 8 weeks.
Weekly visits for assessments during treatment
Duration - 4 weeks
Participants who achieve normal visual acuity continue stereoacuity training for 4 additional weeks, while those with residual amblyopia receive dichoptic movie treatment for 4 additional weeks.
1 to 2 visits depending on treatment response
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Reed M Jost, Krista R Kelly, Eileen E Birch
https://pubmed.ncbi.nlm.nih.gov/37619861/Reed M Jost, Krista R Kelly, Jeffrey S Hunter...
https://pubmed.ncbi.nlm.nih.gov/33045374/Retina Foundation of the Southwest
Lead Sponsor
National Eye Institute (NEI)
Collaborating Sponsor