Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Completed · Not applicable

Conditions studied: Intermittent Exotropia

In brief

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).

Key facts

Study ID

NCT02807350

Run by

Jaeb Center for Health Research

People needed

386

Starts

2017-01-16

Expected to finish

2022-02-15

Last updated by the study team

2026-07-09

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)]

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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