Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Purpose
Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.
Condition
- Amblyopia
Eligibility
- Eligible Ages
- Between 8 Years and 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 8 to <13 years. 2. VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS). 2. VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS). 3. Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA). 3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated). 1. Criteria for strabismic amblyopia: At least one of the following must be met: - Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be <=5 prism diopters (∆) by SPCT at distance and near fixation. - Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). 2. Criteria for anisometropia: At least one of the following criteria must be met: - ≥1.00 D difference between eyes in spherical equivalent (SE). - ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 3. Criteria for combined-mechanism: Both of the following criteria must be met: - A criterion for strabismus is met (see above). - ≥1.00 D difference between eyes in SE OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 4. No more than 2 weeks (cumulative) of prior dichoptic treatment 5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued. 6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: - Hypermetropia of 2.50 D or more by SE - Myopia of amblyopic eye of 0.50D or more SE - Astigmatism of 1.00D or more - Anisometropia of more than 0.50D SE NOTE: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below. NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles). 1. Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: - SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). - SE must not be under corrected by more than 1.50D SE. - Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. - Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >1.00D. - Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes. 2. Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: - For at least 18 weeks OR until VA stability is documented (defined as <1-line change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). - For determining VA stability (non-improvement): - The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), - The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. - NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated. 7. Participant is willing to wear a headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Interpupillary distance of 52mm to 72mm inclusive. 10. Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol. 11. Participant is willing to accept assignment to either continued spectacles/ contact lens wear alone, dichoptic movies/shows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks. 12. Parent understands the protocol and is willing to accept randomization. 13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center staff. 14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.
Exclusion Criteria
- Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction) 2. Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment. 3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment). 4. Myopia greater than -6.00D spherical equivalent in either eye. 5. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted). 6. Diplopia more than once per week over the last week prior to enrollment by parental report. 7. History of light-induced seizures. 8. Known simulator sickness. 9. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded. 10. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Luminopia Group |
dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with current optical correction if needed |
|
|
Experimental Vivid Vision Group |
dichoptic games using the Vivid Vision headset, prescribed approximately 25 minutes per day (treatment time to complete the day's sessions can be split into shorter sessions totaling about 25 minutes each day) 6 days per week with current optical correction if needed |
|
|
Active Comparator Continued Optical Correction Group |
continued full-time optical correction alone if needed |
|
Recruiting Locations
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama 35294
Birmingham, Alabama 35294
University of Arizona
Tucson, Arizona 85711
Tucson, Arizona 85711
Arkansas Childrens
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
Contact:
Adriana P Grigorian, M.D.
Adriana P Grigorian, M.D.
University Eye Center at Ketchum Health
Anaheim, California 92807
Anaheim, California 92807
Univ. of California- Berkeley
Berkeley, California 94720
Berkeley, California 94720
Stanford University
Palo Alto, California 94303
Palo Alto, California 94303
University of California, Davis
Sacramento, California 95817
Sacramento, California 95817
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Chicago, Illinois 60611
Illinois College of Optometry
Chicago, Illinois 60616
Chicago, Illinois 60616
Progressive Eye Care
Lisle, Illinois 60532
Lisle, Illinois 60532
Indiana School of Optometry
Bloomington, Indiana 47405
Bloomington, Indiana 47405
Greater Baltimore Medical Center
Baltimore, Maryland 21204-5809
Baltimore, Maryland 21204-5809
Wilmer Eye Institute
Baltimore, Maryland 21287-9028
Baltimore, Maryland 21287-9028
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Boston Children's Hospital Waltham
Boston, Massachusetts 02453
Boston, Massachusetts 02453
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan 49307
Big Rapids, Michigan 49307
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Zenith Vision Development Center
Duluth, Minnesota 55811
Duluth, Minnesota 55811
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota 55905
Rochester, Minnesota 55905
PineCone Vision Center
Sartell, Minnesota 56377
Sartell, Minnesota 56377
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
Kansas City, Missouri 64108
University of Nebraska Medical Center
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Contact:
Samiksha Fouzdar Jain, MD
402-559-2977
Samiksha Fouzdar Jain, MD
402-559-2977
State University of New York, College of Optometry
New York, New York 10036
New York, New York 10036
Duke University Eye Center
Durham, North Carolina 27710
Durham, North Carolina 27710
University of North Dakota
Grand Forks, North Dakota 58202
Grand Forks, North Dakota 58202
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Ohio State University College of Optometry
Columbus, Ohio 43210-1280
Columbus, Ohio 43210-1280
Rainbow Babies and Children's Hospital Dept of Ophth
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
River View Family Eyecare
Albany, Oregon 97321
Albany, Oregon 97321
OHSU Casey Eye Institute
Portland, Oregon 97239
Portland, Oregon 97239
Pediatric Ophthalmology of Erie
Erie, Pennsylvania 16501
Erie, Pennsylvania 16501
Conestoga Eye
Lancaster, Pennsylvania 17601
Lancaster, Pennsylvania 17601
Wills Eye Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Southern College of Optometry
Memphis, Tennessee 38104
Memphis, Tennessee 38104
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
University of Houston College of Optometry
Houston, Texas 77204
Houston, Texas 77204
San Antonio Eye Center
San Antonio, Texas 78215
San Antonio, Texas 78215
Virginia Pediatric Eye Center
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Spokane Eye Clinical Research
Spokane, Washington 99204
Spokane, Washington 99204
More Details
- NCT ID
- NCT06524882
- Status
- Recruiting
- Sponsor
- Jaeb Center for Health Research