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Full-Time Occlusion Therapy for Intermittent Exotropia in Children (IXT7)

Primary Purpose

Intermittent Exotropia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eye Patch
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Exotropia focused on measuring IXT, intermittent exotropia, occlusion therapy

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:

  1. Age 3 to < 9 years
  2. IXT meeting all of the following criteria:

    • Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia)
    • Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments)
    • Distance exodeviation between 15∆ and 50∆ by PACT
    • Near exodeviation between 0∆ and 50∆ by PACT
    • Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded)
  3. Age-normal visual acuity in both eyes:

    • 3 years: 20/50 or better (>=63 letters)
    • 4 years: 20/40 or better (>=68 letters)
    • 5-6 years: 20/32 or better (>=73 letters)
    • 7-<9 years: 20/25 or better (>=78 letters)
  4. Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥7 years old.
  5. Cycloplegic refraction within the last 7 months.
  6. Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months
  7. Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks:

    • Myopia > -0.50 D spherical equivalent (SE) in either eye
    • Anisometropia > 1.00 D SE
    • Astigmatism in either eye > 1.00 D
  8. Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months:

    • Anisometropia SE must be within 0.50 D of the full anisometropic difference correction
    • Astigmatism must be corrected within 0.50 D
    • Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.
    • For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below).
    • For myopia, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Deliberate overminus is not allowed.
    • Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE

      • Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction.)
    • For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed.
    • Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction.
  9. Gestational age > 30 weeks
  10. Birth weight > 1500 grams
  11. Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months
  12. Parent has phone and is willing to be contacted by Jaeb Center staff
  13. Relocation outside of area of an active PEDIG site within 3 months not anticipated

Exclusion Criteria:

Individuals meeting any of the following criteria at baseline will be excluded from study participation:

  1. Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
  2. Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of >1week duration within the past year
  3. Previous amblyopia treatment other than refractive correction
  4. Diplopia more than 2 times per day by parental assessment
  5. Paretic or restrictive strabismus
  6. Craniofacial malformations affecting the orbits
  7. Ocular disorders which would reduce VA (except refractive error)
  8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded.
  9. Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
  10. Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study.
  11. Known allergy to adhesive patches.
  12. Known allergy to silicone.

Sites / Locations

  • UAB Pediatric Eye Care; Birmingham Health CareRecruiting
  • University of ArizonaRecruiting
  • Arkansas ChildrensRecruiting
  • Univ. of California- BerkeleyRecruiting
  • Southern California College of OptometryRecruiting
  • Univ of California, Irvine- Gavin Herbert Eye InstituteRecruiting
  • Progressive Eye CareRecruiting
  • Boston Medical CenterRecruiting
  • Boston Children's Hospital WalthamRecruiting
  • Michigan College of Optometry at Ferris State UnivRecruiting
  • Mayo Clinic Department of OphthalmologyRecruiting
  • Children's Mercy Hospitals and ClinicsRecruiting
  • University of Nebraska Medical CenterRecruiting
  • State University of New York, College of OptometryRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Ohio State University College of OptometryRecruiting
  • Eye Care Associates, Inc.Recruiting
  • Pacific University College of OptometryRecruiting
  • Casey Eye InstituteRecruiting
  • Salus University/Pennsylvania College of OptometryRecruiting
  • Southern College of OptometryRecruiting
  • University of Houston College of OptometryRecruiting
  • Virginia Pediatric Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation Group

Full Time Patching

Arm Description

Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.

Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.

Outcomes

Primary Outcome Measures

Change in mean distance control scores at 3 months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
August 16, 2023
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
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1. Study Identification

Unique Protocol Identification Number
NCT05462821
Brief Title
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Acronym
IXT7
Official Title
Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), Pediatric Eye Disease Investigator Group

4. Oversight

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

5. Study Description

Brief Summary
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Detailed Description
Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies. The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia
Keywords
IXT, intermittent exotropia, occlusion therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Observation Group
Arm Type
No Intervention
Arm Description
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
Arm Title
Full Time Patching
Arm Type
Experimental
Arm Description
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Intervention Type
Device
Intervention Name(s)
Eye Patch
Intervention Description
adhesive patch to cover eye
Primary Outcome Measure Information:
Title
Change in mean distance control scores at 3 months
Description
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria: Age 3 to < 9 years IXT meeting all of the following criteria: Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia) Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments) Distance exodeviation between 15∆ and 50∆ by PACT Near exodeviation between 0∆ and 50∆ by PACT Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded) Age-normal visual acuity in both eyes: 3 years: 20/50 or better (>=63 letters) 4 years: 20/40 or better (>=68 letters) 5-6 years: 20/32 or better (>=73 letters) 7-<9 years: 20/25 or better (>=78 letters) Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥7 years old. Cycloplegic refraction within the last 7 months. Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks: Myopia > -0.50 D spherical equivalent (SE) in either eye Anisometropia > 1.00 D SE Astigmatism in either eye > 1.00 D Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months: Anisometropia SE must be within 0.50 D of the full anisometropic difference correction Astigmatism must be corrected within 0.50 D Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D. For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below). For myopia, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Deliberate overminus is not allowed. Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction.) For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed. Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction. Gestational age > 30 weeks Birth weight > 1500 grams Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months Parent has phone and is willing to be contacted by Jaeb Center staff Relocation outside of area of an active PEDIG site within 3 months not anticipated Exclusion Criteria: Individuals meeting any of the following criteria at baseline will be excluded from study participation: Prior strabismus, intraocular, or refractive surgery (including BOTOX injection) Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of >1week duration within the past year Previous amblyopia treatment other than refractive correction Diplopia more than 2 times per day by parental assessment Paretic or restrictive strabismus Craniofacial malformations affecting the orbits Ocular disorders which would reduce VA (except refractive error) Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded. Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome) Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study. Known allergy to adhesive patches. Known allergy to silicone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond T Kraker, MSPH
Phone
813-975-8690
Email
rkraker@jaeb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katie M Stutz
Phone
813-975-8690
Email
kstutz@jaeb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen P Christiansen, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erin C Jenewein, OD
Organizational Affiliation
Salus University
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Pediatric Eye Care; Birmingham Health Care
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Hopkins, O.D.
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan M Holmes, MD
Phone
520-321-3677
Email
jmholmes@arizona.edu
Facility Name
Arkansas Childrens
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana P Grigorian, M.D.
Facility Name
Univ. of California- Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer H Fisher, OD
Phone
510-642-2020
Email
jenhfisher@berkeley.edu
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831-1699
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan A. Cotter, O.D.
Phone
714-449-7488
Email
scotter@scco.edu
First Name & Middle Initial & Last Name & Degree
Kristine Huang, O.D.
Phone
714-449-7435
Email
khuang@scco.edu
First Name & Middle Initial & Last Name & Degree
Silvia Han, OD
Facility Name
Univ of California, Irvine- Gavin Herbert Eye Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donny Suh, MD, MBA
Phone
949-824-9089
Email
dowsuh@gmail.com
Facility Name
Progressive Eye Care
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Davis, M.D.
Phone
630-245-0989
Email
idocmd@comcast.net
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Christiansen, MD
Phone
617-414-2020
Email
spchris@bu.edu
Facility Name
Boston Children's Hospital Waltham
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aparna Raghuram, O.D., Ph.D.
Phone
617-355-6401
Email
aparna.raghuram@childrens.harvard.edu
Facility Name
Michigan College of Optometry at Ferris State Univ
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula McDowell
Phone
231-591-2182
Email
PaulaMcDowell@ferris.edu
Facility Name
Mayo Clinic Department of Ophthalmology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick D Bothun, M.D.
Phone
507-284-3760
Email
Bothun.Erick@mayo.edu
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Qayum, MD
Phone
816-701-1337
Email
jvqayum@cmh.edu
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samiksha Fouzdar Jain, MD
Phone
402-559-2977
Facility Name
State University of New York, College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marilyn Vricella, OD
Phone
212-780-5182
Email
mvricella@sunyopt.edu
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gray, MD
Phone
513-636-4751
Email
Michael.Gray@cchmc.org
Facility Name
Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1280
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjean T Kulp, O.D.
Phone
614-688-3336
Email
mtkulp@optometry.ohio-state.edu
First Name & Middle Initial & Last Name & Degree
Marjean T Kulp, O.D.
Facility Name
Eye Care Associates, Inc.
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Ayse Erzurum, M.D.
Phone
330-746-7691
Email
erzurum2020@gmail.com
Facility Name
Pacific University College of Optometry
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Luke, OD
Phone
503-224-2323
Email
pluke@pacificu.edu
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Summers, OD
Phone
503-494-7830
Email
summersa@ohsu.edu
Facility Name
Salus University/Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Jenewein, OD
Phone
215-276-6000
Email
Ejenewein@salus.edu
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Bodack, OD
Phone
901-722-3276
Email
mbodack@sco.edu
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Manny, OD, PhD
Phone
713-743-1944
Email
rmanny@central.uh.edu
Facility Name
Virginia Pediatric Eye Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Crouch, MD
Phone
757-461-0050
Email
ercrouch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
IPD Sharing Time Frame
Data will be made available after publication of each primary manuscript
IPD Sharing Access Criteria
Users accessing the data must enter an email address.
IPD Sharing URL
http://pedig.jaeb.org/

Learn more about this trial

Full-Time Occlusion Therapy for Intermittent Exotropia in Children

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