Bilateral Refractive Amblyopia Treatment Study

NCT00305955 | Completed

• 2 other identifiers: NEI-1012U10EY011751
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bilateral Refractive Amblyopia

Keywords

amblyopia; bilateral amblyopia; refractive error

Outcome Measures

Primary Outcomes (1)

• Visual acuity of 20/25 or better in both eyes

  52 weeks

Interventions

Spectacles DEVICE

optimal spectacle correction

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Wallace DK, Chandler DL, Beck RW, Arnold RW, Bacal DA, Birch EE, Felius J, Frazier M, Holmes JM, Hoover D, Klimek DA, Lorenzana I, Quinn GE, Repka MX, Suh DW, Tamkins S; Pediatric Eye Disease Investigator Group. Treatment of bilateral refractive amblyopia in children three to less than 10 years of age. Am J Ophthalmol. 2007 Oct;144(4):487-96. doi: 10.1016/j.ajo.2007.05.040. Epub 2007 Aug 20.

  PMID: 17707330 RESULT

MeSH Terms

Conditions

Amblyopia; Refractive Errors

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• David K. Wallace, M.D.

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 22, 2006
• Study Start: August 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: October 1, 2006
• Last Updated: March 24, 2010

Record last verified: 2009-10

Locations

US (1)