Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT02807350
Eligibility Criteria:
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 \[e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT02807350
Study Brief:
Protocol Section:
NCT02807350