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Thickness of Retinal Layers in Amblyopia

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179763
First received: August 5, 2010
Last updated: August 10, 2010
Last verified: August 2010

August 5, 2010
August 10, 2010
April 2010
June 2010   (final data collection date for primary outcome measure)
Retinal layer thickness [ Time Frame: One month ] [ Designated as safety issue: No ]
Optical coherence tomography scan will be conducted to analyze retinal layer thickness, when the patient are enrolled.
Same as current
Complete list of historical versions of study NCT01179763 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Thickness of Retinal Layers in Amblyopia
Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia

The purpose of this study is to examine retinal layer thickness in amblyopia.

Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

patients in tertiary hospital

Amblyopia
Other: Optical coherence tomography
Spectral domain optical coherence tomography will be conducted once when patients are enrolled.
Other Name: Spectralis Optical coherence tomography
Retinal layer thickness analysis
Optical coherence tomography will be conducted to analyze retinal layer thickness (safe examination)
Intervention: Other: Optical coherence tomography
Altintas O, Yüksel N, Ozkan B, Caglar Y. Thickness of the retinal nerve fiber layer, macular thickness, and macular volume in patients with strabismic amblyopia. J Pediatr Ophthalmol Strabismus. 2005 Jul-Aug;42(4):216-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Amblyopia

Exclusion Criteria:

  • Other retinal disease
  • Anisometropia
  • Neurologic abnormalities
Both
4 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01179763
2009-12-089
Yes
Se Yeul Oh, M.D., Samsung Medical Center
Samsung Medical Center
Not Provided
Study Chair: Sei Yeul Oh, M.D. Samsung Medical Center
Samsung Medical Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP