3 to 10 years old
child, eye, intermittent exotropia, eye drift
Eye exams Questionnaires Overminus glasses or regular glasses Phone calls Follow up visits
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)
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
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)]
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