Clinical trial NCT06380517: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Official title: A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Amblyopia
Keywords: Dichoptic
Luminopia
Patching
movie
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Pediatric Eye Disease Investigator Group
First posted: 2024-04-24
Enrollment: 238
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization.

At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization.

The study will end for all other participants.

Eligibility criteria: At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.

1. Age 4 to 7 years.
2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV 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.
   2. Age-normal VA in the fellow eye:44,45

      • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
   3. Interocular difference ≥ 3 logMAR lines (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 (see #7 below).
      * 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 spherical equivalent 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: 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 \<0.1 logMAR 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 the Luminopia headset.
8. Participant is willing to continue full-time spectacles/contact lens wear (if needed).
9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks.
10. Interpupillary distance of 52mm to 72mm inclusive.
11. Investigator is willing to prescribe Luminopia or patching per protocol.
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.
14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated.

Individuals meeting any of the following criteria will be excluded from study participation.

1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
2. Prism lenses or need of a prism prescription at 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. Previous intraocular or refractive surgery.
6. Known skin reactions to patch or bandage adhesives.
7. 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).
8. Diplopia more than once per week over the last week prior to enrollment by parental report.
9. History of light-induced seizures.
10. 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.
11. Participation in a prior study involving patching for amblyopia
12. 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.

Primary outcomes:
measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
timeFrame: 26 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Pediatric Eye Care; Birmingham Health Care
state: Alabama
city: Glendale
country: United States
facility: Midwestern University Eye Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Childrens
state: Arkansas
city: Little Rock
country: United States
facility: McFarland Eye Care Center
state: Arkansas
city: Berkeley
country: United States
facility: Univ. of California- Berkeley
state: California
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Irvine
country: United States
facility: Univ of California, Irvine- Gavin Herbert Eye Institute
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles (CHLA)
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute at the University of California, Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Pomona
country: United States
facility: Western University College of Optometry
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Department of Ophthalmology
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida (USF) Eye
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Lisle
country: United States
facility: Progressive Eye Care
state: Illinois
city: Bloomington
country: United States
facility: Indiana School of Optometry
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Beverly
country: United States
facility: Specialized Pediatric Eye Care
state: Massachusetts
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
city: Big Rapids
country: United States
facility: Michigan College of Optometry at Ferris State Univ
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Grand Rapids
country: United States
facility: Pediatric Ophthalmology, P.C.
state: Michigan
city: West Bloomfield
country: United States
facility: Children's Eye Care PC
state: Michigan
city: Duluth
country: United States
facility: Zenith Vision Development Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Department of Ophthalmology
state: Minnesota
city: Sartell
country: United States
facility: PineCone Vision Center
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: State University of New York, College of Optometry
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Grand Forks
country: United States
facility: University of North Dakota
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cole Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Pediatric Ophthalmology Associates, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Mayfield Heights
country: United States
facility: Rainbow Babies and Children's Hospital Dept of Ophth
state: Ohio
city: Poland
country: United States
facility: Eye Care Associates, Inc.
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie
state: Pennsylvania
city: Lancaster
country: United States
facility: Conestoga Eye
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital - Dept. Of Ophthalmology
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: San Antonio
country: United States
facility: University of the Incarnate Word
state: Texas
city: Norfolk
country: United States
facility: Earl R. Crouch, III
state: Virginia
city: Norfolk
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital, University of Washington
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
affiliation: Boston Children's Hospital/ Harvard Medical School
name: Aparna Raghuram, OD, PhD
role: STUDY_CHAIR
affiliation: Wills Eye Hospital
name: Kammi Gunton, MD
role: STUDY_CHAIR
affiliation: Jaeb Center for Health Research
name: Robert Henderson, MS
role: PRINCIPAL_INVESTIGATOR
References: