Bilateral Refractive Amblyopia Treatment Study

Completed

Conditions studied: Bilateral Refractive Amblyopia

In brief

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

Key facts

Study ID

NCT00305955

Run by

Jaeb Center for Health Research

People needed

113

Starts

2004-08-01

Expected to finish

2006-10-01

Last updated by the study team

2010-03-24

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)
• Prior intraocular or refractive surgery
• Use of contact lenses during the study

Where it is running

• Duke University Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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