Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT02807350

Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Sponsor: Jaeb Center for Health Research

View on ClinicalTrials.gov

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).

Official title: A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Key Details

Gender

All

Age Range

3 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2017-01-16

Completion Date

2022-02-15

Last Updated

2026-07-09

Healthy Volunteers

Conditions

Intermittent Exotropia

Interventions

DEVICE

Overminus treatment

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

DEVICE

Non-overminus treatment

spectacles with full cycloplegic refraction without overminus

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 \[e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)\]

Locations (61)

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