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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia (IXT3)

Primary Purpose

Intermittent Exotropia

Status
Completed
Phase
Not Applicable
Locations
United States
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 - 6 Years (Child)All SexesDoes not accept healthy volunteers

The following criteria must be met for the child to be enrolled in the study:

  • Age 3 years to < 7 years
  • Intermittent exotropia (manifest deviation) meeting all of the following criteria:

    • Intermittent exotropia or constant exotropia at distance

      • Mean distance control score of 2 points or more (mean of 3 assessments over the exam)
    • Intermittent exotropia, exophoria, or orthophoria at near

      • 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)
  • No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months.
  • No previous substantial overminus treatment, defined as wearing spectacles that are overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D SE is allowed at any time prior to enrollment).
  • No vision therapy, patching, atropine, or other penalization for amblyopia during the last 2 weeks
  • No prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
  • Cycloplegic refraction within 7 months, but NOT on the day of enrollment
  • Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive
  • Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes
  • No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines)
  • Child must be wearing refractive correction (pre-study spectacles) for at least 1 week if refractive error (based on cycloplegic refraction performed within 7 months) meets any of the following:

    • SE anisometropia ≥1.00 D
    • Astigmatism ≥1.00 D in either eye
    • SE myopia ≥-0.50 D in either eye
  • Refractive correction must meet the following criteria relative to the cycloplegic refraction:

    • SE anisometropia must be within <1.0D of the SE anisometropic difference
    • Astigmatism must be within <1.00D of full magnitude; axis must be within 10 degrees if ≤1.00D, and within 5 degrees if >1.00D.
    • The SE of the spectacles must be within <1.00D of the full cycloplegic refraction SE.

      • A correction that yields at least 1.00 D more minus SE than the cycloplegic refraction SE is considered previous substantial overminus lens treatment and the patient is not eligible.
  • No current contact lens wear
  • No abnormality of the cornea, lens, or central retina
  • Gestational age ≥ 32 weeks
  • Birth weight > 1500 grams
  • No Down syndrome or cerebral palsy
  • No 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.
  • No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
  • No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
  • Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status
  • 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 8 weeks is not anticipated

Sites / Locations

  • Marshall B. Ketchum University
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Overminus Treatment

Non-overminus Treatment

Arm Description

2.50D overminus spectacles

spectacles without overminus or no spectacles

Outcomes

Primary Outcome Measures

Mean Distance Exotropia Control Score
At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. *Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.

Secondary Outcome Measures

Mean Near Exotropia Control Score
At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.
Distribution of Distance Control Score at 8-week Outcome
Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Distribution of Near Control Score at 8-week Outcome
Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Proportion of Subjects With Distance Control Treatment Response
A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Stereoacuity
Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.
Distance Visual Acuity
Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance
Binocular Near Visual Acuity
Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Proportion of Subjects With Near Control Treatment Response
A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

Full Information

First Posted
August 20, 2014
Last Updated
April 11, 2017
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
NCT02223650
Brief Title
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Acronym
IXT3
Official Title
A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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 objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.
Detailed Description
The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to overminus by comparing treatment groups on the following outcomes: Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome) The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome) Adverse effects, near visual acuity outcomes, and spectacle wear compliance

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
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overminus Treatment
Arm Type
Experimental
Arm Description
2.50D overminus spectacles
Arm Title
Non-overminus Treatment
Arm Type
Active Comparator
Arm Description
spectacles without overminus or no spectacles
Intervention Type
Device
Intervention Name(s)
Overminus treatment
Other Intervention Name(s)
Overminus spectacles, Overminus glasses, Overminus therapy
Intervention Description
2.50D overminus spectacles
Intervention Type
Device
Intervention Name(s)
Non-overminus treatment
Intervention Description
spectacles without overminus or no spectacles
Primary Outcome Measure Information:
Title
Mean Distance Exotropia Control Score
Description
At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. *Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Mean Near Exotropia Control Score
Description
At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.
Time Frame
8 weeks
Title
Distribution of Distance Control Score at 8-week Outcome
Description
Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Time Frame
8 weeks
Title
Distribution of Near Control Score at 8-week Outcome
Description
Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.
Time Frame
8 weeks
Title
Proportion of Subjects With Distance Control Treatment Response
Description
A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Time Frame
8 weeks
Title
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame
8 weeks
Title
Stereoacuity
Description
Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.
Time Frame
8 weeks
Title
Distance Visual Acuity
Description
Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance
Time Frame
8 weeks
Title
Binocular Near Visual Acuity
Description
Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.
Time Frame
8 weeks
Title
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame
8 weeks
Title
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame
8 weeks
Title
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
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. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.
Time Frame
8 weeks
Title
Proportion of Subjects With Near Control Treatment Response
Description
A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The following criteria must be met for the child to be enrolled in the study: Age 3 years to < 7 years Intermittent exotropia (manifest deviation) meeting all of the following criteria: Intermittent exotropia or constant exotropia at distance Mean distance control score of 2 points or more (mean of 3 assessments over the exam) Intermittent exotropia, exophoria, or orthophoria at near 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) No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months. No previous substantial overminus treatment, defined as wearing spectacles that are overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D SE is allowed at any time prior to enrollment). No vision therapy, patching, atropine, or other penalization for amblyopia during the last 2 weeks No prior strabismus, intraocular, or refractive surgery (including BOTOX injection) Cycloplegic refraction within 7 months, but NOT on the day of enrollment Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines) Child must be wearing refractive correction (pre-study spectacles) for at least 1 week if refractive error (based on cycloplegic refraction performed within 7 months) meets any of the following: SE anisometropia ≥1.00 D Astigmatism ≥1.00 D in either eye SE myopia ≥-0.50 D in either eye Refractive correction must meet the following criteria relative to the cycloplegic refraction: SE anisometropia must be within <1.0D of the SE anisometropic difference Astigmatism must be within <1.00D of full magnitude; axis must be within 10 degrees if ≤1.00D, and within 5 degrees if >1.00D. The SE of the spectacles must be within <1.00D of the full cycloplegic refraction SE. A correction that yields at least 1.00 D more minus SE than the cycloplegic refraction SE is considered previous substantial overminus lens treatment and the patient is not eligible. No current contact lens wear No abnormality of the cornea, lens, or central retina Gestational age ≥ 32 weeks Birth weight > 1500 grams No Down syndrome or cerebral palsy No 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. No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil) Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status 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 8 weeks is not anticipated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M Holmes, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angela M Chen, OD, MS
Organizational Affiliation
Marshall B. Ketchum University
Official's Role
Study Chair
Facility Information:
Facility Name
Marshall B. Ketchum University
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

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.
Citations:
PubMed Identifier
27506485
Citation
Pediatric Eye Disease Investigator Group; Chen AM, Holmes JM, Chandler DL, Patel RA, Gray ME, Erzurum SA, Wallace DK, Kraker RT, Jensen AA. A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology. 2016 Oct;123(10):2127-36. doi: 10.1016/j.ophtha.2016.06.042. Epub 2016 Aug 6.
Results Reference
result
Links:
URL
http://pedig.jaeb.org
Description
PEDIG Public Website

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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

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