58 Participants Needed

Vision Therapy for Intermittent Exotropia

(VT-IXT Trial)

Recruiting at 5 trial locations
AC
Overseen ByAngela Chen, OD, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Southern California College of Optometry at Marshall B. Ketchum University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The main objective of this randomized trial comparing vision therapy to observation is to determine the short-term effectiveness of vision therapy on distance intermittent exotropia control. The results will help determine whether to proceed to a full-scale, long-term randomized trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is vision therapy safe for humans?

Research on vision therapy, including studies on active vision therapy and overminus lens therapy, suggests it is generally safe for humans, with no significant safety concerns reported in the studies.12345

How is vision therapy different from other treatments for intermittent exotropia?

Vision therapy for intermittent exotropia is unique because it focuses on exercises to improve eye coordination and control, potentially offering higher success rates than surgery alone. It involves office-based vergence/accommodative therapy with home exercises, making it a non-invasive option compared to surgical interventions.678910

Research Team

AC

Angela Chen, OD, MS

Principal Investigator

Southern California College of Optometry at Marshall B. Ketchum University

Eligibility Criteria

This trial is for kids aged 8-16 with a specific eye alignment issue called intermittent exotropia, where one eye occasionally drifts outward. They should have certain levels of control over their eye movement and good depth perception. Kids who plan to move soon or can't commit to the study's process are not eligible.

Inclusion Criteria

You have a mean distance control score of 2 points or more, with at least one measure being 3 points or higher.
Your average near control score is less than 5 points.
I am between 8 and 16 years old.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 20 consecutive weeks of office-based vision therapy with home therapy

20 weeks

Observation

Participants in the observation group receive no treatment unless deterioration criteria are met

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

  • Vision Therapy
Trial OverviewThe study tests if vision therapy can help manage intermittent exotropia better than just watching the condition without treatment. Participants will be randomly assigned to either receive vision therapy or be observed, helping decide if more extensive research is needed.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Vision TherapyExperimental Treatment1 Intervention
Participants will receive 20 consecutive weeks of office-based vision therapy with home therapy.
Group II: ObservationActive Control1 Intervention
Participants will receive no treatment for IXT is received during the study unless one of the deterioration criteria is met.

Vision Therapy is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Vision Therapy for:
  • Intermittent Exotropia
  • Strabismus
  • Convergence Insufficiency
🇨🇦
Approved in Canada as Vision Therapy for:
  • Intermittent Exotropia
  • Strabismus
  • Convergence Insufficiency
🇪🇺
Approved in European Union as Vision Therapy for:
  • Intermittent Exotropia
  • Strabismus
  • Convergence Insufficiency

Find a Clinic Near You

Who Is Running the Clinical Trial?

Southern California College of Optometry at Marshall B. Ketchum University

Lead Sponsor

Trials
24
Recruited
1,400+

Southern College of Optometry

Collaborator

Trials
8
Recruited
390+

Case Western Reserve University

Collaborator

Trials
314
Recruited
236,000+

Salus University

Collaborator

Trials
16
Recruited
1,100+

American Academy of Optometry

Collaborator

Trials
6
Recruited
290+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

Findings from Research

In a study of 186 children with intermittent exotropia (IXT), 31.6% showed improvement in their eye alignment and stereoacuity after 1 year of low-dose part-time patching for 2 hours daily.
Factors such as convergence insufficiency, poor distance stereopsis, and larger exotropic deviation at distance were associated with a better response to part-time patching, suggesting it may be an effective non-surgical treatment option for certain patients.
Factors associated with the effectiveness of part-time patching for intermittent exotropia in children.Choi, H., Kim, SJ., Jung, J., et al.[2022]
In a study involving 20 adults with anisometropic amblyopia, active vision therapy over five sessions led to a significant improvement in best corrected visual acuity (BCVA), with scores improving from 0.37 to 0.14 Log MAR.
The results suggest that even adults can experience plasticity in their visual system, indicating that vision therapy can be beneficial for improving visual acuity in older patients with amblyopia.
Visual Acuity Improvement in Adult Anisometropic Amblyopes After Active Vision Therapy.Sharbatoghli, L., Hashemi, H., Mohamadi, A., et al.[2022]
In a study of 76 children aged 3-8 with intermittent exotropia, alternate part-time patching significantly improved deviation control compared to observation, particularly noted at both near and far distances after 3 and 6 months.
While stereoacuity (the ability to perceive depth) did not show significant differences between the patching and observation groups, the patching group exhibited greater improvements in stereoacuity from baseline, indicating potential benefits beyond just deviation control.
The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial.Akbari, MR., Mehrpour, M., Mirmohammadsadeghi, A.[2021]

References

Factors associated with the effectiveness of part-time patching for intermittent exotropia in children. [2022]
Visual Acuity Improvement in Adult Anisometropic Amblyopes After Active Vision Therapy. [2022]
The influence of alternate part-time patching on control of intermittent exotropia: a randomized clinical trial. [2021]
Impact of active vision therapy compared to conventional patching therapy on visual acuity and stereoacuity in children with amblyopia. [2023]
Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. [2022]
Management of intermittent exotropia using a combination of vision therapy and surgery. [2004]
Intermittent exotropia: comparison of treatments. [2016]
Evaluation of Binocular Vision Therapy Efficacy by 3D Video-Oculography Measurement of Binocular Alignment and Motility. [2018]
The Effects of Orthoptic Therapy on the Surgical Outcome in Children with Intermittent Exotropia: Randomised Controlled Clinical Trial. [2023]
Vision therapy for intermittent exotropia: A case series. [2021]