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

Conditions

• Amblyopia

Eligibility Criteria

Sex

ALL

Age

8 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Vivid Vision — DEVICE
  dichoptic video games played through a virtual reality headset
• Luminopia — DEVICE
  dichoptic movies/shows shown through a virtual reality headset
• Optical Correction — DEVICE
  Glasses prescribed at investigator discretion

Study Details

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.

Key Dates

Start date

Oct 22, 2024

Status verified

Feb 2026

Primary completion

Jul 1, 2027

Completion

Nov 1, 2027

Study Design

Enrollment

252 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change in amblyopic eye logMAR distance VA [ Time Frame: 18 Weeks ]

Central Contacts

• Raymond T Kraker, MSPH
  813-975-8690
  [email protected]
• Brooke P Fimbel
  813-975-8690
  [email protected]

Locations (58)

Find similar trials in Birmingham, AL

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