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Trial of Overminus Spectacle Therapy for Intermittent Exotropia (IXT5)

Primary Purpose

Intermittent Exotropia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Overminus treatment
Non-overminus treatment
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 Intermittent Exotropia, IXT, overminus

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 3 years to < 11 years
  • Intermittent exotropia (manifest deviation) meeting all of the following criteria:

  • At distance: intermittent exotropia or constant exotropia

    o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)

  • At near: intermittent exotropia, exophoria, or orthophoria

    o Subject cannot have a score of 5 points on all 3 near assessments of control

  • Exodeviation at least 15∆ at distance measured by PACT
  • Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)
  • Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older.
  • Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart)
  • Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam.
  • If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment:
  • SE anisometropia ≥1.00D
  • Astigmatism ≥1.50D in either eye
  • SE myopia ≥-1.00D in either eye

Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam:

  • SE anisometropia must be corrected within <1.00D of the SE anisometropic difference
  • Astigmatism must be corrected within <1.00D of full magnitude; axis must be within 10 degrees.
  • The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below)
  • Gestational age ≥ 32 weeks
  • Birth weight > 1500 grams
  • Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles
  • Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff
  • Relocation outside of area of an active PEDIG site within next 18 months is not anticipated

Exclusion Criteria:

  • Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.
  • Current contact lens wear
  • Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)
  • Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
  • Abnormality of the cornea, lens, or central retina
  • Down syndrome or cerebral palsy
  • Severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.
  • Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia
  • Anti-seizure medications [e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)]

Sites / Locations

  • University of Alabama at Birmingham
  • Midwestern University Eye Institute
  • Arkansas Childrens
  • University Eye Center at Ketchum Health
  • Marshall B. Ketchum University
  • Loma Linda University Health Care, Dept. of Ophthalmology
  • Saddleback Eye Medical Associates
  • Stanford University
  • Western University College of Optometry
  • University of California San Francisco Department of Ophthalmology
  • Nova Southeastern University College of Optometry, The Eye Institute
  • University of Florida Shands Hospital
  • Nemours Children's Clinic
  • The Emory Eye Center
  • St Luke's Hospital
  • The Eye Specialists Center, LLC
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Illinois College of Optometry
  • Midwestern U Chicago College of Optometry
  • Pediatric Eye Associates
  • Indiana University School Of Optometry
  • Riley Hospital for Children
  • The Eye Specialist Center, LLC
  • Wolfe Eye Clinic
  • University of Kentucky Department of Neurology
  • Greater Baltimore Medical Center
  • Wilmer Eye Institute
  • Tufts Medical Center
  • Boston Medical Center
  • Helen DeVos Children's Hospital Pediatric Ophthalmology
  • Pediatric Ophthalmology, P.C.
  • Children's Eye Care PC
  • University of Minnesota
  • Mayo Clinic Department of Ophthalmology
  • Children's Mercy Hospitals and Clinics
  • U of MO St. Louis College of Optometry
  • University of Nebraska Medical Center
  • Concord Ophthalmologic Associates
  • State University of New York, College of Optometry
  • Duke University Eye Center
  • Akron Children's Hospital
  • Cincinnati Children's Hospital
  • The Ohio State University College of Optometry
  • Eye Care Associates, Inc.
  • Dean A. McGee Eye Institute, University of Oklahoma
  • Pacific University College of Optometry
  • Casey Eye Institute
  • Conestoga Eye
  • Salus University/Pennsylvania College of Optometry
  • UPMC Children's Eye Center of Children's Hospital of Pittsburgh
  • Medical University of South Carolina, Storm Eye Institute
  • Pediatric Eye Specialists
  • Southern College of Optometry
  • Texas Children's Hospital - Dept. Of Ophthalmology
  • University of Houston College of Optometry
  • Texas Tech University Health Science Center
  • Houston Eye Associates
  • Virginia Pediatric Eye Center
  • Gundersen Health System
  • Alberta Children's Hospital
  • CHU - Sainte-Justine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Overminus Treatment

Non-overminus Treatment

Arm Description

spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere

spectacles with full cycloplegic refraction without overminus

Outcomes

Primary Outcome Measures

Mean Distance Control at 12-Months (On-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Mean Distance Control at 18-Months (Off-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). 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

Number of Participants With No Spontaneous Tropia
The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
No Spontaneous Tropia
The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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).
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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).
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Near Control (12 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). 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).
Near Control (18 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). 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).
Change in Near Control (12 Months)
For each timepoint, the change in near control since baseline will be reported. 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).
Change in Near Control (18 Months)
For each timepoint, the change in near control since baseline will be reported. 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).
Angle Magnitude (12 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Angle Magnitude (18 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Stereoacuity at 12 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Stereoacuity at 18 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Compliance With Spectacle Wear (12 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Compliance With Spectacle Wear (18 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Parent Symptom Survey [12 Months]
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Parent Symptom Survey [18 Months]
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.

Full Information

First Posted
June 16, 2016
Last Updated
May 11, 2022
Sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02807350
Brief Title
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Acronym
IXT5
Official Title
A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score. The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
Detailed Description
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: The long-term on-treatment effect of overminus treatment on distance IXT control score. The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment). The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy: Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)? Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued? In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Overminus Treatment
Arm Type
Experimental
Arm Description
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Arm Title
Non-overminus Treatment
Arm Type
Active Comparator
Arm Description
spectacles with full cycloplegic refraction without overminus
Intervention Type
Device
Intervention Name(s)
Overminus treatment
Other Intervention Name(s)
Overminus spectacles, Overminus glasses, Overminus therapy
Intervention Description
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Intervention Type
Device
Intervention Name(s)
Non-overminus treatment
Intervention Description
spectacles with full cycloplegic refraction without overminus
Primary Outcome Measure Information:
Title
Mean Distance Control at 12-Months (On-Treatment Visit)
Description
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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
12 months
Title
Mean Distance Control at 18-Months (Off-Treatment Visit)
Description
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). 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
18 months
Secondary Outcome Measure Information:
Title
Number of Participants With No Spontaneous Tropia
Description
The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time Frame
12 months
Title
No Spontaneous Tropia
Description
The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Time Frame
At 18 months
Title
Change in Distance Control
Description
The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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
12 months
Title
Change in Distance Control
Description
The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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
18 months
Title
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
Description
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time Frame
12 months
Title
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
Description
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group. Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint. Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control. Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day. Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Time Frame
18 months
Title
Near Control (12 Months)
Description
Mean control of the near exodeviation (average of 3 measurements over the exam). 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
12 months
Title
Near Control (18 Months)
Description
Mean control of the near exodeviation (average of 3 measurements over the exam). 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
18 months
Title
Change in Near Control (12 Months)
Description
For each timepoint, the change in near control since baseline will be reported. 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
12 months
Title
Change in Near Control (18 Months)
Description
For each timepoint, the change in near control since baseline will be reported. 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
18 months
Title
Angle Magnitude (12 Months)
Description
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time Frame
12 months
Title
Angle Magnitude (18 Months)
Description
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Time Frame
18 months
Title
Stereoacuity at 12 Months
Description
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time Frame
12 months
Title
Stereoacuity at 18 Months
Description
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Time Frame
18 months
Title
Compliance With Spectacle Wear (12 Months)
Description
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time Frame
12 months
Title
Compliance With Spectacle Wear (18 Months)
Description
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Time Frame
18 months
Title
Parent Symptom Survey [12 Months]
Description
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time Frame
At 12 months
Title
Parent Symptom Survey [18 Months]
Description
A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.
Time Frame
At 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 3 years to < 11 years Intermittent exotropia (manifest deviation) meeting all of the following criteria: At distance: intermittent exotropia or constant exotropia o Mean distance control score of 2 points or more (mean of 3 assessments over the exam) At near: intermittent exotropia, exophoria, or orthophoria o Subject cannot have a score of 5 points on all 3 near assessments of control Exodeviation at least 15∆ at distance measured by PACT Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded) Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older. Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart) Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam. If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment: SE anisometropia ≥1.00D Astigmatism ≥1.50D in either eye SE myopia ≥-1.00D in either eye Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam: SE anisometropia must be corrected within <1.00D of the SE anisometropic difference Astigmatism must be corrected within <1.00D of full magnitude; axis must be within 10 degrees. The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below) Gestational age ≥ 32 weeks Birth weight > 1500 grams Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff Relocation outside of area of an active PEDIG site within next 18 months is not anticipated Exclusion Criteria: Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization. Current contact lens wear Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam) Prior strabismus, intraocular, or refractive surgery (including BOTOX injection) Abnormality of the cornea, lens, or central retina Down syndrome or cerebral palsy Severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded. Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia Anti-seizure medications [e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Chen, OD, MS
Organizational Affiliation
Marshall B. Ketchum University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
S. Ayse Erzurum, MD
Organizational Affiliation
Eye Care Associates, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Midwestern University Eye Institute
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Arkansas Childrens
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
University Eye Center at Ketchum Health
City
Anaheim
State/Province
California
ZIP/Postal Code
92807
Country
United States
Facility Name
Marshall B. Ketchum University
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Loma Linda University Health Care, Dept. of Ophthalmology
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Saddleback Eye Medical Associates
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Western University College of Optometry
City
Pomona
State/Province
California
ZIP/Postal Code
91766
Country
United States
Facility Name
University of California San Francisco Department of Ophthalmology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Nova Southeastern University College of Optometry, The Eye Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33382
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
The Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St Luke's Hospital
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
The Eye Specialists Center, LLC
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Midwestern U Chicago College of Optometry
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Pediatric Eye Associates
City
Wilmette
State/Province
Illinois
ZIP/Postal Code
60091
Country
United States
Facility Name
Indiana University School Of Optometry
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The Eye Specialist Center, LLC
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kentucky Department of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204-5809
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-9028
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Helen DeVos Children's Hospital Pediatric Ophthalmology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Pediatric Ophthalmology, P.C.
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Children's Eye Care PC
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Mayo Clinic Department of Ophthalmology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
U of MO St. Louis College of Optometry
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Concord Ophthalmologic Associates
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
State University of New York, College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1280
Country
United States
Facility Name
Eye Care Associates, Inc.
City
Poland
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
Facility Name
Dean A. McGee Eye Institute, University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Pacific University College of Optometry
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Conestoga Eye
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Salus University/Pennsylvania College of Optometry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina, Storm Eye Institute
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Pediatric Eye Specialists
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Texas Children's Hospital - Dept. Of Ophthalmology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
Texas Tech University Health Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Houston Eye Associates
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Virginia Pediatric Eye Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
CHU - Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

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.
Citations:
PubMed Identifier
33662112
Citation
Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Melia BM, Bhatt AR, Suh DW, Vricella M, Erickson JW, Miller AM, Marsh JD, Bodack MI, Martinson SR, Titelbaum JR, Gray ME, Holtorf HL, Kong L, Kraker RT, Rahmani B, Shah BK, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Apr 1;139(4):464-476. doi: 10.1001/jamaophthalmol.2021.0082.
Results Reference
result
PubMed Identifier
35412528
Citation
Holmes JM, Leske DA, Hercinovic A, Hatt SR, Chandler DL, Li Z, Melia BM, Chen AM, Erzurum SA, Crouch ER, Jenewein EC, Kraker RT, Cotter SA; Pediatric Eye Disease Investigator Group. Rasch-calibrated Intermittent Exotropia Symptom Questionnaire for Children. Optom Vis Sci. 2022 Jun 1;99(6):513-520. doi: 10.1097/OPX.0000000000001901. Epub 2022 Apr 12.
Results Reference
derived
Links:
URL
http://pedig.jaeb.org/
Description
PEDIG public website

Learn more about this trial

Trial of Overminus Spectacle Therapy for Intermittent Exotropia

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