Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Jaeb Center for Health Research
- Study ID
- NCT06380517
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Amblyopia
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - 7 Years
- Healthy Volunteers
- Not accepted
Interventions
- Luminopia — DEVICEdichoptic movies/shows shown through a virtual reality headset
- Eye Patch — OTHERProcedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Study Details
In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.
Key Dates
- Start date
- Jul 1, 2024
- Status verified
- Feb 2026
- Primary completion
- Jul 1, 2027
- Completion
- Jan 1, 2028
Study Design
- Enrollment
- 238 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Luminopia Groupwatching 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 optical correction, if needed.
- Active Comparator: Patching Grouppatching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.
Primary Outcome Measure
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks [ Time Frame: 26 Weeks ]
Central Contacts
- Raymond T Kraker, MSPH813-975-8690
- Brooke P Fimbel813-975-8690
Locations (73)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UAB Pediatric Eye Care; Birmingham Health Care | Birmingham | Alabama | 35294 | Kristine Hopkins, O.D. (PRINCIPAL_INVESTIGATOR) |
| Midwestern University Eye Institute | Glendale | Arizona | 85308 | Christina A Esposito, OD (SUB_INVESTIGATOR) |
| Phoenix Children's Medical Group - Ophthalmology | Scottsdale | Arizona | 85255 | |
| University of Arizona | Tucson | Arizona | 85711 | |
| Arkansas Childrens | Little Rock | Arkansas | 72202 | Adriana P Grigorian, M.D. |
| McFarland Eye Care Center | Little Rock | Arkansas | 72205 | |
| Univ. of California- Berkeley | Berkeley | California | 94720 | |
| Southern California College of Optometry | Fullerton | California | 92831-1699 | Silvia Han, OD (SUB_INVESTIGATOR) |
| Univ of California, Irvine- Gavin Herbert Eye Institute | Irvine | California | 92697 | |
| Children's Hospital of Los Angeles (CHLA) | Los Angeles | California | 90027 | Melinda Chang, MD |
| Jules Stein Eye Institute at the University of California, Los Angeles | Los Angeles | California | 90095 | |
| Stanford University | Palo Alto | California | 94303 | |
| Western University College of Optometry | Pomona | California | 91766 | |
| University of California, Davis | Sacramento | California | 95817 | Benjamin G Jastrzembski, MD |
| Rady Children's Hospital - San Diego Dept of Ophthalmology | San Diego | California | 92123 | |
| University of California San Francisco Department of Ophthalmology | San Francisco | California | 94143 | |
| Yale University | New Haven | Connecticut | 06511 | |
| University of South Florida (USF) Eye | Tampa | Florida | 33620 | Syeda Basith |
| The Emory Eye Center | Atlanta | Georgia | 30322 | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Hawke H Yoon, MD (PRINCIPAL_INVESTIGATOR) Safa Rahmani, MD (SUB_INVESTIGATOR) |
| Illinois College of Optometry | Chicago | Illinois | 60616 | |
| Midwestern University Eye Institute | Downers Grove | Illinois | 60515 | |
| Progressive Eye Care | Lisle | Illinois | 60532 | |
| Indiana School of Optometry | Bloomington | Indiana | 47405 | |
| University of Iowa | Iowa City | Iowa | 52242 | Sara J Downes |
| University of Kansas Dept of Ophthalmology | Prairie Village | Kansas | 66208 | |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204-5809 | |
| Wilmer Eye Institute | Baltimore | Maryland | 21287-9028 | |
| Specialized Pediatric Eye Care | Beverly | Massachusetts | 01915 | Danielle M Ledoux, MD |
| Boston Children's Hospital Waltham | Boston | Massachusetts | 02453 | |
| Boston Medical Center | Boston | Massachusetts | 02118 | Jenna Titelbaum, OD 617-414-2020 |
| New England College of Optometry | Boston | Massachusetts | 02115 | |
| University of Michigan | Ann Arbor | Michigan | 48105 | |
| Michigan College of Optometry at Ferris State Univ | Big Rapids | Michigan | 49307 | |
| Corewell Health | Grand Rapids | Michigan | 49503 | |
| Pediatric Ophthalmology, P.C. | Grand Rapids | Michigan | 49546 | |
| Children's Eye Care PC | West Bloomfield | Michigan | 48322 | |
| Zenith Vision Development Center | Duluth | Minnesota | 55811 | |
| University of Minnesota | Minneapolis | Minnesota | 55454 | Sasha Strul, M.D |
| Mayo Clinic Department of Ophthalmology | Rochester | Minnesota | 55905 | |
| PineCone Vision Center | Sartell | Minnesota | 56377 | |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | |
| University of Nebraska Medical Center | Omaha | Nebraska | 68114 | Samiksha Fouzdar Jain, MD (402)559-2977 |
| Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology | Buffalo | New York | 14209 | |
| NYU Langone Health | New York | New York | 10017 | Zachary Elkin, MD |
| State University of New York, College of Optometry | New York | New York | 10036 | |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | |
| Duke University Eye Center | Durham | North Carolina | 27710 | Nathan L Cheung, OD |
| University of North Dakota | Grand Forks | North Dakota | 58202 | David H Biberdorf |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | |
| Cole Eye Institute | Cleveland | Ohio | 44195 | |
| Ohio State University College of Optometry | Columbus | Ohio | 43210-1280 | Marjean T Kulp, O.D. (PRINCIPAL_INVESTIGATOR) |
| Pediatric Ophthalmology Associates, Inc. | Columbus | Ohio | 43205 | |
| Rainbow Babies and Children's Hospital Dept of Ophth | Mayfield Heights | Ohio | 44124 | |
| Eye Care Associates, Inc. | Poland | Ohio | 44514 | |
| Casey Eye Institute | Portland | Oregon | 97239 | |
| Pediatric Ophthalmology of Erie | Erie | Pennsylvania | 16501 | |
| Conestoga Eye | Lancaster | Pennsylvania | 17601 | |
| Pennsylvania College of Optometry, Salus at Drexel University | Philadelphia | Pennsylvania | 19141 | |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | |
| Prisma Health | Columbia | South Carolina | 29203 | Katie Keck, MD |
| Storm Eye Institute | Mt. Pleasant | South Carolina | 29464 | James Bowsher |
| Southern College of Optometry | Memphis | Tennessee | 38104 | |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232-8808 | Sean P. Donahue, M.D., Ph.D. |
| Texas Children's Hospital - Dept. Of Ophthalmology | Houston | Texas | 77030 | |
| Texas Tech University Health Science Center | Lubbock | Texas | 79430 | |
| University of the Incarnate Word | San Antonio | Texas | 78209 | Raelyn Ottenbreit, OD |
| Earl R. Crouch, III | Norfolk | Virginia | 23502-3942 | Earl R. Crouch, III, M.D. (757) 461-0050 Earl R. Crouch, III, M.D. (PRINCIPAL_INVESTIGATOR) |
| Virginia Pediatric Eye Center | Norfolk | Virginia | 23502 | |
| Seattle Children's Hospital, University of Washington | Seattle | Washington | 98105 | Vivian Manh, O.D., M.S> (PRINCIPAL_INVESTIGATOR) |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | |
| Gundersen Health System | La Crosse | Wisconsin | 54601 |
Find similar trials in Birmingham, AL
By research site
Related Studies
- Binocular Amblyopia TreatmentRecruiting · Retina Foundation of the Southwest · Dallas, Texas
- Visual Function Abnormalities in Strabismus and Amblyopia and Response to TherapyRecruiting · The Cleveland Clinic · Cleveland, Ohio
- A Randomized Trial to Evaluate Sequential vs Simultaneous PatchingPHASE3 · Recruiting · Jaeb Center for Health Research · Birmingham, Alabama
- Video Treatment for AmblyopiaRecruiting · Retina Foundation of the Southwest · Dallas, Texas