Bilateral Refractive Amblyopia Treatment Study (NCT00305955) | Clinical Trial Compass
CompletedNot Applicable
Bilateral Refractive Amblyopia Treatment Study
United States113 participantsStarted 2004-08
Plain-language summary
The purpose of this study will be to:
* Determine the amount of visual acuity improvement with treatment of presumed bilateral refractive amblyopia
* Determine the time course of visual acuity improvement with treatment
Who can participate
Age range3 Years – 10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 3 to \<11 years
* Able to perform single-surrounded single optotype visual acuity using the ATS HOTV protocol for children 3 to \<7 years old and using the E-ETDRS protocol for children 7 to \<11 years old
* Monocular visual acuity in each eye, measured using trial frames or phoropter with best correction derived from cycloplegic refraction, meeting the following criteria:
* Using E-ETDRS testing for patients age 7 to \<11 years: visual acuity 20 to 70 letters (20/40 to 20/400)
* Using ATS HOTV testing for patients age 3 to \<7 years acuity 20/50 to 20/400
* Refractive error that meets at least one of the following criteria in each eye:
* Spherical equivalent \>+4.00 D
* Astigmatism \>2.00 D
* Investigator believes that the patient's reduced visual acuity is due to bilateral, refractive amblyopia
* Investigator not planning to prescribe occlusion, patching or any other amblyopia treatment other than spectacles at this time
* Cycloplegic refraction and ocular examination within 2 months prior to enrollment
Exclusion Criteria:
* Myopia greater than -6.00 D of spherical power in plus cylinder form
* Ocular cause for decreased acuity in either eye; nystagmus per se will not exclude a patient from the study
* Refractive correction (spectacles or contact lenses) in past three months and no more than one month of refractive correction ever
* Prior treatment for amblyopia (other than the refractive correction permitted in previous exclusion criteria)
* Pr…