NCT07272005

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
27mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Aug 2028

First Submitted

Initial submission to the registry

November 19, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

November 19, 2025

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in control of intermittent exotropia

    change percent time alignment is present at 8 weeks vs at baseline

    8 weeks

Secondary Outcomes (7)

  • Improvement in control of intermittent exotropia

    4 weeks

  • Improvement in control of intermittent exotropia

    12 weeks off-treatment

  • Change in distance stereoacuity

    4 weeks

  • Change in distance stereoacuity

    8 weeks

  • Change in distance stereoacuity

    12 weeks off-treatment

  • +2 more secondary outcomes

Study Arms (2)

Group 1: Dichoptic Videos

EXPERIMENTAL

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

Other: dichoptic videos

Group 2: Standard Videos

SHAM COMPARATOR

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

Other: standard videos

Interventions

standard videos

Group 2: Standard Videos

custom designed dichoptic videos

Group 1: Dichoptic Videos

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

RECRUITING

Study Officials

  • Eileen E Birch

    Retina Foundation of the Southwest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pediatric Vision Laboratory

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations