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

History of Changes

Purpose

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

Condition	Intervention
Amblyopia	Other: Optical coherence tomography

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

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.

Enrollment:	22
Study Start Date:	April 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Retinal layer thickness analysis Optical coherence tomography will be conducted to analyze retinal layer thickness (safe examination)	Other: Optical coherence tomography Spectral domain optical coherence tomography will be conducted once when patients are enrolled. Other Name: Spectralis Optical coherence tomography

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	4 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients in tertiary hospital

Criteria

Inclusion Criteria:

Amblyopia

Exclusion Criteria:

Other retinal disease
Anisometropia
Neurologic abnormalities

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179763

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

Study Chair:

Sei Yeul Oh, M.D.

Samsung Medical Center

More Information

Publications:

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.

Responsible Party:	Se Yeul Oh, M.D., Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01179763 History of Changes
Other Study ID Numbers:	2009-12-089
Study First Received:	August 5, 2010
Last Updated:	August 10, 2010
Health Authority:	Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Amblyopia
Retinal layer thickness

Additional relevant MeSH terms:

Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders

Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013

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