Amblyopia
Conditions
Brief summary
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.
Detailed description
To date, all studies of contrast-rebalanced binocular amblyopia treatment games used the same 10% per day contrast-increment that was designed for short-term intervention studies lasting 1-4 weeks; i.e., after 18 days of successful game play, both eyes viewed 100% contrast (no contrast-rebalancing).This study will investigate two alternative protocols designed to extend the game treatment period beyond 4 weeks to allow for more complete recovery of visual acuity. The new protocols will be compared with the original 10% contrast-increment game protocol in an 8-week 3-arm RCT to determine whether one or both of the new protocols is more effective than the current 10% increment. Based on pilot data, we expect about 40% of amblyopic children to achieve normal visual acuity in 8 weeks. In an effort to also promote recovery of binocular vision, children who attain ≤0.4 logMAR at 8 weeks will be enrolled in stereoacuity training at the 8-week visit for the next 4 weeks. Children with residual amblyopia (BCVA \>0.4 logMAR) at the 8-week visit will be provided with dichoptic movies for additional amblyopia treatment for another 4 weeks.
Interventions
OTHERBinocular games for treatment of amblyopia
playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye
Sponsors
Retina Foundation of the Southwest
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* age 4-10 y * male and female * strabismic, anisometropic, or combined mechanism amblyopia * amblyopic eye best-corrected visual acuity 0.3-0.8 logMAR * fellow eye best-corrected visual acuity ≤0.1 logMAR * interocular visual acuity difference ≥0.3 logMAR * wearing glasses (if needed) for 8 weeks or no change visual acuity with glasses at 2 visits * 4 weeks apart. * child's ophthalmologist and family must be willing to forgo patching treatment during the 12-week study period * parent's informed consent * child must demonstrate understanding and ability to play binocular games
Exclusion criteria
* prematurity ≥8 weeks * coexisting ocular or systemic disease * developmental delay * strabismus \>5pd * any binocular amblyopia treatment in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity of the amblyopic eye | baseline vs 8 weeks | ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual acuity of the amblyopic eye | baseline vs 2, 4, 6, and 12 weeks | ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years |
| Change in stereoacuity | baseline vs 2, 4, 6, 8, 12 weeks | Randot Preschool Stereoacuity Test |
| Change in suppression | baseline vs 2, 4, 6, 8, 12 weeks | Dichoptic Letter Chart |
Countries
United States
Contacts
CONTACTReed Jost, MS
CONTACTKrista Kelly, PhD
Outcome results
None listed