Thickness of Retinal Layers in Amblyopia

Amblyopia Clinical Trial

Official title:

Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179763
• Other study ID #: 2009-12-089
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: August 10, 2010
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 19 Years

Eligibility

Inclusion Criteria:

• Amblyopia

Exclusion Criteria:

• Other retinal disease

• Anisometropia

• Neurologic abnormalities

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amblyopia

Intervention

Other:
• Optical coherence tomography
Spectral domain optical coherence tomography will be conducted once when patients are enrolled.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal layer thickness	Optical coherence tomography scan will be conducted to analyze retinal layer thickness, when the patient are enrolled.	One month	No