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 Sex
- 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 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
Midwestern University Eye Institute
Glendale 5295985, Arizona 5551752 85308
Glendale 5295985, Arizona 5551752 85308
University of Arizona
Tucson 5318313, Arizona 5551752 85711
Tucson 5318313, Arizona 5551752 85711
Arkansas Childrens
Little Rock 4119403, Arkansas 4099753 72202
Little Rock 4119403, Arkansas 4099753 72202
Contact:
Adriana P Grigorian, M.D.
Adriana P Grigorian, M.D.
McFarland Eye Care Center
Little Rock 4119403, Arkansas 4099753 72205
Little Rock 4119403, Arkansas 4099753 72205
University Eye Center at Ketchum Health
Anaheim 5323810, California 5332921 92807
Anaheim 5323810, California 5332921 92807
Univ. of California- Berkeley
Berkeley 5327684, California 5332921 94720
Berkeley 5327684, California 5332921 94720
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine 5359777, California 5332921 92697
Irvine 5359777, California 5332921 92697
Stanford University
Palo Alto 5380748, California 5332921 94303
Palo Alto 5380748, California 5332921 94303
Western University College of Optometry
Pomona 5384170, California 5332921 91766
Pomona 5384170, California 5332921 91766
University of California, Davis
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
University of California San Francisco Department of Ophthalmology
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
University of South Florida (USF) Eye
Tampa 4174757, Florida 4155751 33620
Tampa 4174757, Florida 4155751 33620
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Illinois College of Optometry
Chicago 4887398, Illinois 4896861 60616
Chicago 4887398, Illinois 4896861 60616
Midwestern University Eye Institute
Downers Grove 4890119, Illinois 4896861 60515
Downers Grove 4890119, Illinois 4896861 60515
Progressive Eye Care
Lisle 4900080, Illinois 4896861 60532
Lisle 4900080, Illinois 4896861 60532
Indiana School of Optometry
Bloomington 4254679, Indiana 4921868 47405
Bloomington 4254679, Indiana 4921868 47405
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
University of Kansas Dept of Ophthalmology
Prairie Village 4277718, Kansas 4273857 66208
Prairie Village 4277718, Kansas 4273857 66208
Greater Baltimore Medical Center
Baltimore 4347778, Maryland 4361885 21204-5809
Baltimore 4347778, Maryland 4361885 21204-5809
Wilmer Eye Institute
Baltimore 4347778, Maryland 4361885 21287-9028
Baltimore 4347778, Maryland 4361885 21287-9028
New England College of Optometry
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Boston 4930956, Massachusetts 6254926 02118
Boston Children's Hospital Waltham
Boston 4930956, Massachusetts 6254926 02453
Boston 4930956, Massachusetts 6254926 02453
Michigan College of Optometry at Ferris State Univ
Big Rapids 4986020, Michigan 5001836 49307
Big Rapids 4986020, Michigan 5001836 49307
Pediatric Ophthalmology, P.C.
Grand Rapids 4994358, Michigan 5001836 49546
Grand Rapids 4994358, Michigan 5001836 49546
Zenith Vision Development Center
Duluth 5024719, Minnesota 5037779 55811
Duluth 5024719, Minnesota 5037779 55811
University of Minnesota-Minnesota Lions Children's Eye Clinic
Minneapolis 5037649, Minnesota 5037779 55454
Minneapolis 5037649, Minnesota 5037779 55454
Mayo Clinic Department of Ophthalmology
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
PineCone Vision Center
Sartell 5046001, Minnesota 5037779 56377
Sartell 5046001, Minnesota 5037779 56377
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678 64108
Kansas City 4393217, Missouri 4398678 64108
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
Contact:
Samiksha Fouzdar Jain, MD
(402)559-2977
Samiksha Fouzdar Jain, MD
(402)559-2977
NYU Langone Health
New York 5128581, New York 5128638 10017
New York 5128581, New York 5128638 10017
State University of New York, College of Optometry
New York 5128581, New York 5128638 10036
New York 5128581, New York 5128638 10036
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Duke University Eye Center
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
University of North Dakota
Grand Forks 5059429, North Dakota 5690763 58202
Grand Forks 5059429, North Dakota 5690763 58202
Cincinnati Children's Hospital
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Cole Eye Institute
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
Ohio State University College of Optometry
Columbus 4509177, Ohio 5165418 43210-1280
Columbus 4509177, Ohio 5165418 43210-1280
Rainbow Babies and Children's Hospital Dept of Ophth
Mayfield Heights 5162188, Ohio 5165418 44124
Mayfield Heights 5162188, Ohio 5165418 44124
River View Family Eyecare
Albany 5710756, Oregon 5744337 97321
Albany 5710756, Oregon 5744337 97321
OHSU Casey Eye Institute
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Pediatric Ophthalmology of Erie
Erie 5188843, Pennsylvania 6254927 16501
Erie 5188843, Pennsylvania 6254927 16501
Conestoga Eye
Lancaster 5197079, Pennsylvania 6254927 17601
Lancaster 5197079, Pennsylvania 6254927 17601
Wills Eye Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Southern College of Optometry
Memphis 4641239, Tennessee 4662168 38104
Memphis 4641239, Tennessee 4662168 38104
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
University of Houston College of Optometry
Houston 4699066, Texas 4736286 77204
Houston 4699066, Texas 4736286 77204
San Antonio Eye Center
San Antonio 4726206, Texas 4736286 78215
San Antonio 4726206, Texas 4736286 78215
Virginia Pediatric Eye Center
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
Spokane Eye Clinical Research
Spokane 5811696, Washington 5815135 99204
Spokane 5811696, Washington 5815135 99204
More Details
- NCT ID
- NCT06524882
- Status
- Recruiting
- Sponsor
- Jaeb Center for Health Research