Using Dichoptic Therapy to Treat Intermittent Exotropia

Conditions

• Exotropia Intermittent

Eligibility Criteria

Sex

ALL

Age

4 Years - 7 Years

Healthy Volunteers

Not accepted

Interventions

• Luminopia, a virtual reality headset — DEVICE
  Subjects will be provided with the equipment to use in their homes for six hours usage per week (1 hour 6 days a week), for 12 weeks.
• Paper pre- survey — OTHER
  Pre-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team
• Paper Survey — OTHER
  Post-survey to be completed by the parent and child. Questions may be skipped. Survey developed by the study team

Study Details

Intermittent exotropia is difficult to treat. The mainstay of treatment involves surgery, and in one long-term study authors found that as many as 60% of IXT required at least one re-operation.Patching of the non-dominant eye has also been tested in a large, multi-center randomized control trial and was not found to have a large benefit. More non-surgical treatment modalities are critical to improve the care in this condition.

Key Dates

Start date

Jul 26, 2024

Status verified

Oct 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Luminopia VR headset treatment
  Using Dichoptic Therapy to Improve Intermittent Exotropia Control in children ages 4-7

Primary Outcome Measure

Dichoptic therapy change of control of intermittent exotropia using the standard control score [ Time Frame: 3 months for primary response, and 6 months after a washout period (3 months without the device) ]

Central Contacts

• Evan Silverstein
  804-828-2467
  [email protected]
• Emilia Varrone
  804-828-9315
  [email protected]

Locations (1)

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