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

Primary Purpose

Intermittent Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Office-based accommodative/vergence therapy and home reinforcement
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Observation

    Office-based accommodative/vergence therapy and home reinforcement

    Arm Description

    Observation only.

    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)

    Outcomes

    Primary Outcome Measures

    Comparison of the distant office control score between two groups at the primary outcome visit
    Comparison of the distant office control score between two groups at the primary outcome visit

    Secondary Outcome Measures

    Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
    Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score

    Full Information

    First Posted
    February 4, 2021
    Last Updated
    February 21, 2021
    Sponsor
    Sun Yat-sen University
    Collaborators
    Salus University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04744779
    Brief Title
    Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia
    Official Title
    Effectiveness of Office Based Vergence/Accommodative Therapy for the Treatment of Intermittent Exotropia: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Salus University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intermittent Exotropia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Observation
    Arm Type
    No Intervention
    Arm Description
    Observation only.
    Arm Title
    Office-based accommodative/vergence therapy and home reinforcement
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Office-based accommodative/vergence therapy and home reinforcement
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Comparison of the distant office control score between two groups at the primary outcome visit
    Description
    Comparison of the distant office control score between two groups at the primary outcome visit
    Time Frame
    16 months
    Secondary Outcome Measure Information:
    Title
    Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
    Description
    Comparison of percentage of patients showing ≥ 1 point change and ≥ 2 points change in office control score
    Time Frame
    16 months
    Other Pre-specified Outcome Measures:
    Title
    Comparison of deterioration rate between 2 groups
    Description
    Comparison of deterioration rate between 2 groups
    Time Frame
    16 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 6 to <18 years old Distance exodeviation between 10 and 30 prism diopters (PD) measured by prism and alternate cover test (PACT) Near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type intermittent exotropia excluded) 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 Stereoacuity: near stereoacuity of 400 arcsec or better by the Preschool Randot stereotest Cycloplegic subjective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +3.50 D inclusive in either eye 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 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 Gestational age >34 weeks Birth weight >1500 g 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) No prior office-based vision therapy for any reason No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery No planned strabismus surgery 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: Amblyopia, nystagmus, restrictive or paretic strabismus 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 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 Relocation anticipated within 2 year Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus Vertical deviation greater than 3 pd Household member already in the study

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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