NCT04199871

Brief Summary

Aim 1: To determine whether use of dichoptic movies for 4 weeks may be helpful in improving control of alignment in children with intermittent exotropia (IXT), thus allowing IXT to be managed non-surgically Aim 2: To determine pre-IXT surgery use of dichoptic movies for 4 weeks post-operatively may be helpful in maintaining successful control of alignment in children who have surgical correction of IXT

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

December 11, 2019

Last Update Submit

January 23, 2025

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (1)

  • Alignment Control Score

    Classification system developed by PEDIG to quantify the degree of control of ocular alignment on a 0-5 scale at distance and near; 0 is best control \[no exotropia unless dissociated, recovers in \<1 second (phoria)\] and 5 is worst control (constant exotropia)

    3 months

Secondary Outcomes (3)

  • Stereoacuity at distance

    3 months

  • Binocular fixation stability

    3 months

  • Stereoacuity at near

    3 months

Study Arms (2)

Group1

EXPERIMENTAL

dichoptic 3D movies

Other: dichoptic 3D movies

Group 2

SHAM COMPARATOR

dichoptic standard movies

Other: dichoptic 3D movies

Interventions

dichoptic 3D moviesOTHER

dichoptic movies presented on a Nintendo 3DS

Also known as: dichoptic standard movies
Group 2Group1

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of IXT
  • IXT control assessment score at distance of 3 or 4 at baseline
  • Ocular misalignment by PACT \>10 pd at distance and near or PACT \>15 at distance or near

You may not qualify if:

  • Amblyopia
  • Prior surgery
  • Prior binocular treatment
  • Coexisting ocular or systemic condition
  • Developmental delay

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eileen E Birch

Dallas, Texas, 75231, United States

Location

Study Officials

  • Eileen E Birch, PhD

    Retina Foundation of the Southwest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

March 25, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)