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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00926549
Other study ID # 3-2008-0048
Secondary ID
Status Recruiting
Phase N/A
First received May 6, 2009
Last updated June 19, 2009
Start date May 2009
Est. completion date September 2009

Study information

Verified date June 2009
Source Yonsei University
Contact Sung Soo Kim, MD, PhD
Phone 82-2-2019-3443
Email semekim@naver.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to analyze macular retinal thickness and macular volume using the spectral domain - optical coherence tomography (SD-OCT) in normal eyes and in eyes with various ocular diseases.


Description:

Assessment of macular thickness is important for the treatment and follow-up of a variety of ocular diseases. The introduction of optical coherence tomography (OCT) has enabled clinicians to reliably detect small changes in macular thickness and to quantitatively evaluate the efficacy of different therapeutic modalities. In this study using the spectral domain-OCT, we examined the variations of macular retinal thickness and macular volume in normal eyes and in eyes with various ocular diseases.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 85 Years
Eligibility Inclusion Criteria:

- normal eyes

- myopic eyes

- hypermetropic eyes

Exclusion Criteria:

- systemic illness

- cataract

- previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
macular cube scanning

Locations

Country Name City State
Korea, Republic of Yonsei University College of Medicine, Gangnam Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary macular retinal thickness and volume 3 months No
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