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Binocular Amblyopia Treatment

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ClinicalTrials.gov Identifier: NCT03288948
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Retina Foundation of the Southwest

Brief Summary:
To evaluate the effectiveness of enhanced binocular amblyopia treatments in achieving a more complete and stable recovery.

Condition or disease Intervention/treatment Phase
Amblyopia Other: Binocular games for treatment of amblyopia Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Binocular Amblyopia Treatment
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Active Comparator: Standard Contrast Increment Other: Binocular 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

Experimental: Reduced Contrast Increment Other: Binocular 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

Experimental: No Contrast Increment Other: Binocular 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




Primary Outcome Measures :
  1. Change in visual acuity of the amblyopic eye [ Time Frame: baseline vs 8 weeks ]
    ATS-HOTV for age 4-6.9 years or E-ETDRS for age 7-10.9 years


Secondary Outcome Measures :
  1. Change in visual acuity of the amblyopic eye [ Time Frame: 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

  2. Change in stereoacuity [ Time Frame: baseline vs 2, 4, 6, 8, 12 weeks ]
    Randot Preschool Stereoacuity Test

  3. Change in suppression [ Time Frame: baseline vs 2, 4, 6, 8, 12 weeks ]
    Dichoptic Letter Chart


Other Outcome Measures:
  1. Change in accommodation [ Time Frame: baseline vs 8 week ]
    Accuracy of accommodation to a near target (Grand Seiko)

  2. Change in motion perception [ Time Frame: baseline vs 8 weeks ]
    Motion-defined form

  3. Change in fixation stability [ Time Frame: baseline vs 8 weeks ]
    Bivariate contour ellipse area

  4. Reading speed [ Time Frame: baseline vs 4 and 8 weeks ]
    Reading speed in wpm

  5. Fine motor skills [ Time Frame: baseline vs 4 and 8 weeks ]
    M-ABC

  6. Self-perception [ Time Frame: baseline vs 8 weeks ]
    self-perception questionnaire



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288948


Contacts
Contact: Reed Jost, MS 2143633911 ext 113 reedjost@retinafoundation.org
Contact: Krista Kelly, PhD 2143633911 ext 113 kkelly@rfsw.org

Locations
United States, Texas
Retina Foundation of the Southwest Recruiting
Dallas, Texas, United States, 75231
Contact: Pediatric Laboratory    214-363-3911 ext 113      
Principal Investigator: Eileen E Birch, PhD         
Sponsors and Collaborators
Retina Foundation of the Southwest

Responsible Party: Retina Foundation of the Southwest
ClinicalTrials.gov Identifier: NCT03288948     History of Changes
Other Study ID Numbers: 062010-105
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: we will only share aggregated data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms