Actively Recruiting

Phase 3
Age: 8Years - 12Years
All Genders
NCT06524882

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Led by Jaeb Center for Health Research · Updated on 2026-02-11

252

Participants Needed

58

Research Sites

157 weeks

Total Duration

On this page

Sponsors

J

Jaeb Center for Health Research

Lead Sponsor

N

National Eye Institute (NEI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Who Can Participate

Age: 8Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 8 and less than 13 years
  • Visual acuity in amblyopic eye between 20/40 and 20/200
  • Visual acuity in fellow eye 20/25 or better
  • At least 3 logMAR lines difference between eyes
  • Amblyopia due to strabismus, anisometropia, or both
  • No more than 2 weeks prior dichoptic treatment
  • No cycloplegic eyedrops in past 2 weeks
  • Requires refractive correction based on recent cycloplegic refraction
  • Willing to wear headset
  • Willing to wear full-time glasses or contact lenses if needed
  • Interpupillary distance between 52mm and 72mm
  • Investigator agrees to prescribe treatment per protocol
  • Willing to accept randomization to any treatment group for 19 weeks
  • Parent understands the study and agrees to randomization
  • Parent has phone access and agrees to contact
  • No planned relocation from study area for 36 weeks
Not Eligible

You will not qualify if you...

  • More than 5 prism diopters heterotropia at distance or near
  • Prism correction greater than 8 diopters horizontal or 1 diopter vertical
  • Current bifocal glasses (unless discontinued 2 weeks prior)
  • Myopia worse than -6.00 diopters in either eye
  • Eye conditions that reduce visual acuity other than amblyopia
  • Diplopia occurring more than once per week recently
  • History of light-induced seizures
  • Known simulator sickness
  • Severe developmental delays affecting treatment or evaluation
  • Immediate family member involved in the study or JAEB center staff

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 58 locations

1

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Midwestern University Eye Institute

Glendale, Arizona, United States, 85308

Actively Recruiting

3

Phoenix Children's Medical Group - Ophthalmology

Scottsdale, Arizona, United States, 85255

Actively Recruiting

4

University of Arizona

Tucson, Arizona, United States, 85711

Actively Recruiting

5

Arkansas Childrens

Little Rock, Arkansas, United States, 72202

Actively Recruiting

6

McFarland Eye Care Center

Little Rock, Arkansas, United States, 72205

Actively Recruiting

7

University Eye Center at Ketchum Health

Anaheim, California, United States, 92807

Actively Recruiting

8

Univ. of California- Berkeley

Berkeley, California, United States, 94720

Actively Recruiting

9

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California, United States, 92697

Actively Recruiting

10

Stanford University

Palo Alto, California, United States, 94303

Actively Recruiting

11

Western University College of Optometry

Pomona, California, United States, 91766

Actively Recruiting

12

University of California, Davis

Sacramento, California, United States, 95817

Actively Recruiting

13

University of California San Francisco Department of Ophthalmology

San Francisco, California, United States, 94143

Actively Recruiting

14

Nova Southeastern University College of Optometry, The Eye Institute

Fort Lauderdale, Florida, United States, 33382

Actively Recruiting

15

University of South Florida (USF) Eye

Tampa, Florida, United States, 33620

Actively Recruiting

16

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

17

Illinois College of Optometry

Chicago, Illinois, United States, 60616

Actively Recruiting

18

Midwestern University Eye Institute

Downers Grove, Illinois, United States, 60515

Actively Recruiting

19

Progressive Eye Care

Lisle, Illinois, United States, 60532

Actively Recruiting

20

Indiana School of Optometry

Bloomington, Indiana, United States, 47405

Actively Recruiting

21

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

22

University of Kansas Dept of Ophthalmology

Prairie Village, Kansas, United States, 66208

Actively Recruiting

23

Greater Baltimore Medical Center

Baltimore, Maryland, United States, 21204-5809

Actively Recruiting

24

Wilmer Eye Institute

Baltimore, Maryland, United States, 21287-9028

Actively Recruiting

25

New England College of Optometry

Boston, Massachusetts, United States, 02115

Actively Recruiting

26

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

27

Boston Children's Hospital Waltham

Boston, Massachusetts, United States, 02453

Actively Recruiting

28

Michigan College of Optometry at Ferris State Univ

Big Rapids, Michigan, United States, 49307

Actively Recruiting

29

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

30

Zenith Vision Development Center

Duluth, Minnesota, United States, 55811

Actively Recruiting

31

University of Minnesota-Minnesota Lions Children's Eye Clinic

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

32

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, United States, 55905

Actively Recruiting

33

PineCone Vision Center

Sartell, Minnesota, United States, 56377

Actively Recruiting

34

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States, 64108

Actively Recruiting

35

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68114

Actively Recruiting

36

NYU Langone Health

New York, New York, United States, 10017

Actively Recruiting

37

State University of New York, College of Optometry

New York, New York, United States, 10036

Actively Recruiting

38

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

39

Duke University Eye Center

Durham, North Carolina, United States, 27710

Actively Recruiting

40

University of North Dakota

Grand Forks, North Dakota, United States, 58202

Actively Recruiting

41

Cincinnati Children's Hospital

Cincinnati, Ohio, United States, 45229

Actively Recruiting

42

Cole Eye Institute

Cleveland, Ohio, United States, 44195

Actively Recruiting

43

Ohio State University College of Optometry

Columbus, Ohio, United States, 43210-1280

Actively Recruiting

44

Rainbow Babies and Children's Hospital Dept of Ophth

Mayfield Heights, Ohio, United States, 44124

Actively Recruiting

45

River View Family Eyecare

Albany, Oregon, United States, 97321

Actively Recruiting

46

OHSU Casey Eye Institute

Portland, Oregon, United States, 97239

Actively Recruiting

47

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, United States, 16501

Actively Recruiting

48

Conestoga Eye

Lancaster, Pennsylvania, United States, 17601

Actively Recruiting

49

Wills Eye Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

50

Salus University/Pennsylvania College of Optometry

Philadelphia, Pennsylvania, United States, 19141

Actively Recruiting

51

Storm Eye Institute

Mt. Pleasant, South Carolina, United States, 29464

Actively Recruiting

52

Southern College of Optometry

Memphis, Tennessee, United States, 38104

Actively Recruiting

53

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

54

University of Houston - College of Optometry

Houston, Texas, United States, 77204

Actively Recruiting

55

University of Houston College of Optometry

Houston, Texas, United States, 77204

Actively Recruiting

56

San Antonio Eye Center

San Antonio, Texas, United States, 78215

Actively Recruiting

57

Virginia Pediatric Eye Center

Norfolk, Virginia, United States, 23502

Actively Recruiting

58

Spokane Eye Clinical Research

Spokane, Washington, United States, 99204

Actively Recruiting

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Research Team

R

Raymond T Kraker, MSPH

CONTACT

B

Brooke P Fimbel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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