Clinical trial NCT06524882: Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Official title: A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Amblyopia
Keywords: Dichoptic
Luminopia
Vivid Vision
Game
movie
glasses
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Pediatric Eye Disease Investigator Group
First posted: 2024-07-29
Enrollment: 252
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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.

Primary outcomes:
measure: Change in amblyopic eye logMAR distance VA
timeFrame: 18 Weeks
Secondary outcomes:
measure: Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Pediatric Eye Care; Birmingham Health Care
state: Alabama
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: Anaheim
country: United States
facility: University Eye Center at Ketchum Health
state: California
city: Berkeley
country: United States
facility: Univ. of California- Berkeley
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: 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: 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: Pediatric Ophthalmology, P.C.
state: Michigan
city: Duluth
country: United States
facility: Zenith Vision Development Center
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: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
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: 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: Albany
country: United States
facility: River View Family Eyecare
state: Oregon
city: Portland
country: United States
facility: OHSU 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: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
affiliation: Ohio State University
name: Marjean T Kulp, OD
role: STUDY_CHAIR
affiliation: University of California, Davis
name: Benajmin G Jastrzembski, MD
role: STUDY_CHAIR
References: