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Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

Primary Purpose

Intermittent Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
accommodative/vergence therapy
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

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 8 to 18 years old
  2. deviation meeting all of the following criteria: A. intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control> or = Grade 2) B. intermittent exotropia at near (at least 1 of 3 assessments of near control at the baseline visit Grade 2-4) C. distance and near exodeviation both between 15 to 35 prism diopters (PD) measured by prism and alternate cover test (PACT); D. near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type IXT excluded)
  3. cycloplegic objective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +1.00 D inclusive in either eye
  4. Patients must be wearing the updated refractive correction (spectacles or contact lenses) for at least 1 week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following:

    A. Myopia >-0.50 D spherical equivalent in either eye B. Anisometropia >1.00 D spherical equivalent C. Astigmatism in either eye >1.50 D

  5. Refractive correction must meet the following guidelines:

    A. Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic difference B. Astigmatism cylinder must be within 0.25 D of full correction and axis must be within 5 degree C. 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 +1.50 D spherical equivalent hyperopia or -0.50 D spherical equivalent myopia

  6. Gestational age >34 weeks
  7. Birth weight >1500 g
  8. No previous surgical or nonsurgical treatment for IXT other than single vision refractive correction (e.g. PALs, Bifocals, patching, or deliberate over-minus with spectacles more than 0.50 D)
  9. No vision therapy or orthoptics for any reason within the last year
  10. No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
  11. No strabismus surgery planned
  12. vision correctable to at least 20/25 or better at distance and near in each eye.
  13. Px needs to have a computer at home which can connect to internet

Exclusion Criteria:

  1. Patient with nystagmus, restrictive or paretic strabismus
  2. Patient with amblyopia, which is defined as >or = 0.2 logarithm of the minimum angle of resolution units of interocular difference and > or = 0.3 logarithm of the minimum angle of resolution units in one eye ( Variability of stereoacuity in intermittent exotropia)
  3. Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months;
  4. 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;
  5. Relocation anticipated for 2 years;
  6. Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus
  7. Vertical deviation greater than 1 pd in cover test
  8. Household member already in the study.
  9. Any eye care professional, ophthalmic technician, medical student, or optometry student

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Accommodative/vergence therapy

Arm Description

Accommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.

Outcomes

Primary Outcome Measures

Office based intermittent exotropia control score
Office based intermittent exotropia control score is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 5(worst score, constant tropia). Change in Office based intermittent exotropia control score after 14 weeks of vision therapy

Secondary Outcome Measures

Look And Cover, then Ten seconds of Observation Scale for Exotropia(LACTOSE)
Look And Cover, then Ten seconds of Observation Scale for Exotropia (LACTOSE) is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 4(worst score, constant tropia). Change in score after 14 weeks of vision therapy.
Newcastle Control Score
Newcastle Control Score is an office based and home based score to assess the control of intermittent exotropia. Minimum score is 0 (best score) and Maximum score is 6(worst score). Change in score after 14 weeks of vision therapy.Change in score after 14 weeks of vision therapy.
Chinese intermittent exotropia questionnaire
Change in Chinese intermittent exotropia questionnaire after 14 weeks of vision therapy.
Preschool randot near stereoacuity
Change in near stereopsis by Preschool randot near stereoacuity after 14 weeks of vision therapy.
deviation angle
Change in size of distant deviation angle by prism alternating cover test after 14 weeks of vision therapy.

Full Information

First Posted
October 15, 2017
Last Updated
June 26, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03321838
Brief Title
Office Based Vergence and Accommodative Therapy and Intermittent Exotropia
Official Title
Pilot Study of Office Based Vergence and Accommodative Therapy as Treatment of Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This pilot study is designed specifically to determine the short-term effect of OBVAT on intermittent exotropia in terms of 4 key areas (Standardizing reported outcomes of surgery for intermittent exotropia): control score, alignment, near stereoacuity and quality of life score. Result of this pilot study will be used to determine whether a full-scale RCT should be conducted to evaluate the short and long term effectiveness of OBVAT.
Detailed Description
All enrolled px received 16-20 sessions of OBVAT, 60 minutes per visit, one time per week; Home reinforcement, 15 minutes each time, five times per week. Primary outcome measure: A. Change in the office based intermittent exotropia control score Secondary outcome measures A. Change in Look And Cover, then Ten seconds of Observation Scale for Exotropia (LACTOSE) B. Change in Newcastle Control Score (NCS) C. Change in Chinese intermittent exotropia questionnaire (CIXTQ) D. Change in near stereopsis by Preschool randot near stereoacuity E. Change in size of distant deviation angle by prism alternating cover test F. Change in size of near deviation angle by prism alternating cover test

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Accommodative/vergence therapy
Arm Type
Experimental
Arm Description
Accommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.
Intervention Type
Behavioral
Intervention Name(s)
accommodative/vergence therapy
Intervention Description
Accommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.
Primary Outcome Measure Information:
Title
Office based intermittent exotropia control score
Description
Office based intermittent exotropia control score is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 5(worst score, constant tropia). Change in Office based intermittent exotropia control score after 14 weeks of vision therapy
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Secondary Outcome Measure Information:
Title
Look And Cover, then Ten seconds of Observation Scale for Exotropia(LACTOSE)
Description
Look And Cover, then Ten seconds of Observation Scale for Exotropia (LACTOSE) is an office based score to assess the control of intermittent exotropia. Minimum score is 0 (best score, phoria) and Maximum score is 4(worst score, constant tropia). Change in score after 14 weeks of vision therapy.
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Title
Newcastle Control Score
Description
Newcastle Control Score is an office based and home based score to assess the control of intermittent exotropia. Minimum score is 0 (best score) and Maximum score is 6(worst score). Change in score after 14 weeks of vision therapy.Change in score after 14 weeks of vision therapy.
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Title
Chinese intermittent exotropia questionnaire
Description
Change in Chinese intermittent exotropia questionnaire after 14 weeks of vision therapy.
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Title
Preschool randot near stereoacuity
Description
Change in near stereopsis by Preschool randot near stereoacuity after 14 weeks of vision therapy.
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)
Title
deviation angle
Description
Change in size of distant deviation angle by prism alternating cover test after 14 weeks of vision therapy.
Time Frame
Baseline visit, 7th visit(7 weeks after BL), 15th visit (15 weeks after BL)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 8 to 18 years old deviation meeting all of the following criteria: A. intermittent or constant exotropia at distance (mean of 3 baseline assessments of distance control> or = Grade 2) B. intermittent exotropia at near (at least 1 of 3 assessments of near control at the baseline visit Grade 2-4) C. distance and near exodeviation both between 15 to 35 prism diopters (PD) measured by prism and alternate cover test (PACT); D. near deviation not exceeding the distance deviation by >10PD by PACT (i.e., convergence insufficiency type IXT excluded) cycloplegic objective refraction spherical equivalent (SE) refractive error between -6.00 diopters (D)and +1.00 D inclusive in either eye Patients must be wearing the updated refractive correction (spectacles or contact lenses) for at least 1 week if refractive error (based on cycloplegic refraction performed within 6 months) meets any of the following: A. Myopia >-0.50 D spherical equivalent in either eye B. Anisometropia >1.00 D spherical equivalent C. Astigmatism in either eye >1.50 D Refractive correction must meet the following guidelines: A. Anisometropia spherical equivalent must be within 0.25 D of the full anisometropic difference B. Astigmatism cylinder must be within 0.25 D of full correction and axis must be within 5 degree C. 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 +1.50 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 IXT other than single vision refractive correction (e.g. PALs, Bifocals, patching, or deliberate over-minus with spectacles more than 0.50 D) No vision therapy or orthoptics for any reason within the last year No prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery No strabismus surgery planned vision correctable to at least 20/25 or better at distance and near in each eye. Px needs to have a computer at home which can connect to internet Exclusion Criteria: Patient with nystagmus, restrictive or paretic strabismus Patient with amblyopia, which is defined as >or = 0.2 logarithm of the minimum angle of resolution units of interocular difference and > or = 0.3 logarithm of the minimum angle of resolution units in one eye ( Variability of stereoacuity in intermittent exotropia) Regular use of any ocular or systemic medications known to affect accommodation or vergence system, such as atropine, pirenzepine, and anti-epileptic medications in 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 for 2 years; Significant ocular or neurologic disorders (e.g. cerebral palsy) other than strabismus Vertical deviation greater than 1 pd in cover test Household member already in the study. Any eye care professional, ophthalmic technician, medical student, or optometry student
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen xiang
Organizational Affiliation
associate chief physician
Official's Role
Study Director
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31834152
Citation
Ma MM, Kang Y, Scheiman M, Chen X. Office-based Vergence and Accommodative Therapy for the Treatment of Intermittent Exotropia: A Pilot Study. Optom Vis Sci. 2019 Dec;96(12):925-933. doi: 10.1097/OPX.0000000000001454.
Results Reference
derived

Learn more about this trial

Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

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