Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia

February 21, 2021 updated by: Ying Kang, Sun Yat-sen University

Effectiveness of Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia: A Randomized Clinical Trial

Effectiveness of office based vergence/accommodative therapy for the treatment of intermittent exotropia is investigated through a randomized clinical trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose of study:

i) To evaluate the short-term effectiveness of office based vergence/accommodative therapy (OBVAT) for improving control of intermittent exotropia compared to observation alone; ii) To evaluate the long-term effectiveness of OBVAT for improving control of intermittent exotropia compared to observation alone; iii) To determine the natural history of intermittent exotropia among patients aged 6 to < 18 years who have baseline near stereoacuity of 400 arc sec or better using the Preschool Randot stereotest

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 6 to <18 years old
  2. Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and alternate cover test (PACT)
  3. Near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type intermittent exotropia excluded)

  4. Control of deviation meeting all the following criteria based on the office control score scale:

    4.1 Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 2)# 4.2 Intermittent exotropia or exophoria at near (at least 1 of 3 assessments of near control at the baseline visit Grade 0-4) or orthophoria

  5. Stereoacuity: near stereoacuity of 400 arcsec or better by the Preschool Randot stereotest
  6. Cycloplegic subjective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +3.50 D inclusive in either eye

  7. Must be wearing the updated refractive correction (spectacles) for at least 2 weeks if refractive error (based on cycloplegic subjective refraction performed within 6 months) meets any of the following:

    7.1 Myopia >-0.50 D spherical equivalent in either eye 7.2 Anisometropia >1.00 D spherical equivalent 7.3 Astigmatism in either eye >1.50 D

  8. Refractive correction must meet the following guidelines:

    8.1 Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic difference 8.2 Astigmatism cylinder must be within 0.25 D of full correction and axis must be within 5 degree 8.3 For hyperopia and myopia, the spherical component can be reduced by investigator discretion provided reduction is symmetrical and results in residual (i.e., uncorrected) spherical equivalent refractive error that does not exceed +3.50 D spherical equivalent hyperopia or -0.50 D spherical equivalent myopia

  9. Gestational age >34 weeks
  10. Birth weight >1500 g
  11. No previous surgical or nonsurgical treatment for intermittent exotropia other than single vision refractive correction (e.g. progressive addition lens, bifocals, patching, or deliberate over-minus with spectacles >0.50 D)
  12. No prior office-based vision therapy for any reason
  13. No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
  14. No planned strabismus surgery

  15. Visual acuity correctable to at least 20/25 or better at distance and near in each eye.

    • Inclusion criteria 4.1 may be changed to "Intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control ≥ Grade 1" if there is difficulty in patient recruitment.

Exclusion Criteria:

  1. Amblyopia, nystagmus, restrictive or paretic strabismus
  2. Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications, in the most recent 3 months
  3. Developmental disability, attention-deficit/hyperactivity disorder (ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment
  4. Relocation anticipated within 2 year
  5. Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus
  6. Vertical deviation greater than 3 pd
  7. Household member already in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Observation
Observation only.
Experimental: Office-based accommodative/vergence therapy and home reinforcement
Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks)
Behavioral: Office-based accommodative/vergence therapy and home reinforcement
Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of the distant office control score between two groups at the primary outcome visit
Time Frame: 16 months
Comparison of the distant office control score between two groups at the primary outcome visit
16 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
Time Frame: 16 months
Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
16 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison of deterioration rate between 2 groups
Time Frame: 16 months
Comparison of deterioration rate between 2 groups
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Salus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XT4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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