Trial of Overminus Spectacle Therapy for Intermittent Exotropia
NCT ID: NCT02807350
Last Updated: 2022-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
386 participants
INTERVENTIONAL
2017-01-16
2022-02-15
Brief Summary
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* 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).
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Overminus Treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Overminus treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Non-overminus Treatment
spectacles with full cycloplegic refraction without overminus
Non-overminus treatment
spectacles with full cycloplegic refraction without overminus
Interventions
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Overminus treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Non-overminus treatment
spectacles with full cycloplegic refraction without overminus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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 \[e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)\]
3 Years
10 Years
ALL
No
Sponsors
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Pediatric Eye Disease Investigator Group
NETWORK
National Eye Institute (NEI)
NIH
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Angela M Chen, OD, MS
Role: STUDY_CHAIR
Marshall B. Ketchum University
S. Ayse Erzurum, MD
Role: STUDY_CHAIR
Eye Care Associates, Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
Arkansas Childrens
Little Rock, Arkansas, United States
University Eye Center at Ketchum Health
Anaheim, California, United States
Marshall B. Ketchum University
Fullerton, California, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
Saddleback Eye Medical Associates
Mission Viejo, California, United States
Stanford University
Palo Alto, California, United States
Western University College of Optometry
Pomona, California, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
The Emory Eye Center
Atlanta, Georgia, United States
St Luke's Hospital
Boise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Illinois College of Optometry
Chicago, Illinois, United States
The Eye Specialists Center, LLC
Chicago Ridge, Illinois, United States
Midwestern U Chicago College of Optometry
Downers Grove, Illinois, United States
Pediatric Eye Associates
Wilmette, Illinois, United States
Indiana University School Of Optometry
Bloomington, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
The Eye Specialist Center, LLC
Munster, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
University of Kentucky Department of Neurology
Lexington, Kentucky, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Helen DeVos Children's Hospital Pediatric Ophthalmology
Grand Rapids, Michigan, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States
Children's Eye Care PC
West Bloomfield, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
U of MO St. Louis College of Optometry
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Concord Ophthalmologic Associates
Concord, New Hampshire, United States
State University of New York, College of Optometry
New York, New York, United States
Duke University Eye Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
The Ohio State University College of Optometry
Columbus, Ohio, United States
Eye Care Associates, Inc.
Poland, Ohio, United States
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, United States
Pacific University College of Optometry
Portland, Oregon, United States
Casey Eye Institute
Portland, Oregon, United States
Conestoga Eye
Lancaster, Pennsylvania, United States
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, United States
Pediatric Eye Specialists
Chattanooga, Tennessee, United States
Southern College of Optometry
Memphis, Tennessee, United States
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, United States
University of Houston College of Optometry
Houston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
Houston Eye Associates
The Woodlands, Texas, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, United States
Gundersen Health System
La Crosse, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
CHU - Sainte-Justine
Montreal, Quebec, Canada
Countries
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References
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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.
Writing Committee for the Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group; Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Wu R, Vricella M, Waters AL, Ticho BH, Erickson JW, Han S, McDowell PS, Li Z, Kraker RT, Holmes JM, Cotter SA. Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia. JAMA Ophthalmol. 2024 May 1;142(5):417-428. doi: 10.1001/jamaophthalmol.2024.0276.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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PEDIG public website
Other Identifiers
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IXT5
Identifier Type: -
Identifier Source: org_study_id
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