Study of overminus glasses compared to regular glasses for Intermittent Exotropia (eye drift)

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"Do glasses with special lenses (overminus glasses) help with eye drift?"
Age:
3 to 10 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
child, eye, intermittent exotropia, eye drift
Type:
Device study
Investigator:
Description
Intermittent exotropia is the medical term used when an eye drifts out some of the time and at other times both eyes are straight. Intermittent exotropia is one of the most common types of eye misalignment in children.
Intermittent exotropia is often treated using glasses with special lenses (overminus glasses). These glasses are like those prescribed for near-sighted people. These glasses make the eyes work harder in order to see clearly. The extra work is thought to help make the eye drift out less frequently. We believe that overminus glasses may help your child but we do not know this and the study is being done to find out.
This study requires
Eye exams
Questionnaires
Overminus glasses or regular glasses
Phone calls
Follow up visits
Who can participate?
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)]
Resources
Schedule
Study duration and period
1.5 years
Recruitment period
From Sept. 22, 2016
Location
UC Davis Eye Center
4860 Y Street
Suite 2400
Sacramento, CA 95817
Contact
Denise Macias
Research Topic
Conditions:
  • Intermittent Exotropia

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