Improving Control of Intermittent Exotropia

NCT ID: NCT07272005

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-08-31

Brief Summary

To determine whether use of dichoptic movies for 8 weeks may be helpful in improving control alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically

Detailed Description

Intermittent exotropia (IXT) is the most common form of strabismus, characterized by an outward deviation of the eyes that is primarily manifest during distance fixation and can intermittently be controlled by fusional mechanisms. Less than 30% of children have good long-term outcomes following treatment for spontaneously manifest IXT with current non-surgical treatments (prism therapy, over-minus lenses, or vision therapy). The limited efficacy of current non-surgical treatments for IXT is thought to arise from underlying sensory deficits, particularly interocular suppression, which compromises binocular function. This underscores the need for sensory-directed interventions aimed at reducing suppression and thereby enhancing the potential for stable binocular outcomes.

In this study, children will be randomized to watch engaging videos streamed at home that are either dichoptic or standard (control) format. The aim is to determine whether the dichoptic format will decrease suppression and improve control of eye alignment . In previous research, use of dichoptic games and movies by children with amblyopia has shown to reduce suppression.

Conditions

Intermittent Exotropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Dichoptic Videos

dichoptic videos streamed at home 1 hour per day, 5 days per week

Group Type: EXPERIMENTAL

dichoptic videos

Intervention Type: OTHER

custom designed dichoptic videos

Group 2: Standard Videos

standard videos streamed at home 1 hour per day, 5 days per week

Group Type: SHAM_COMPARATOR

standard videos

Intervention Type: OTHER

standard videos

Interventions

dichoptic videos

custom designed dichoptic videos

Intervention Type: OTHER

standard videos

standard videos

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of IXT or XT at Distance & IXT or XP at near (Basic or Pseudo Divergence Excess subtype of IXT)
• No surgery planned for 6 months

Exclusion Criteria

• Prior eye muscle surgery
• Prior binocular treatment or vision therapy
• Amblyopia
• Neurological conditions, seizure disorders, vestibular abnormalities, or frequent headache
• Other eye conditions (refractive error OK)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Retina Foundation of the Southwest

OTHER

Sponsor Role: lead

Responsible Party

Eileen Birch

Director, Pediatric Vision Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eileen E Birch

Role: PRINCIPAL_INVESTIGATOR

Retina Foundation of the Southwest

Central Contacts

Eileen Birch, PhD

Role: CONTACT

ebirch@retinafoundation.org

2143633911

Reed Jost, MS

Role: CONTACT

reedjost@retinafoundation.org

2143633911

Other Identifiers

03 IXT2 2026

Identifier Type: -

Identifier Source: org_study_id