- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551601
Subfoveal Choroidal Thickness in Thai Population
August 12, 2019 updated by: Yosanan Yospaiboon, Khon Kaen University
The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai eyes and study the associations with gender, age, refractive error and axial length using spectral-domain optical coherence tomography with enhanced depth imaging technique.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Alteration of choroidal blood supply causes changes in choroidal thickness and results in choroidal abnormalities.
These are usually associated with retinal diseases and leading to severe visual dysfunction.
Choroidal thickness is therefore helpful in diagnosis and treatment for many chorioretinal conditions.
With the advent of spectral domain optical coherence tomography and enhanced depth imaging technique, choroidal thickness has been investigated widely in normal eyes and various chorioretinal diseases including central serous chorioretinopathy (CSC), age-related macular degeneration (AMD), highly myopia and Vogt Koyanagi-Harada disease.
Similar to retinal thickness, a normal baseline choroidal thickness might be used for interpretation.
This value might be affected by several variables including age, gender and ethnicity.
Although there were previous studies on subfoveal choroidal thickness in normal eyes from many countries, there has been no such study in Thailand.
The purpose of this study was to determine the subfoveal choroidal thickness in normal Thai eyes and study the associations with gender, age, refractive error and axial length using SD-OCT and EDI technique.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Eye outpatients department, Srinagarind Hospital, Khon Kaen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers, age 18 years or above, no ocular diseases
Description
Inclusion Criteria:
- Age 18 years or above
- Healthy subjects
- No ocular diseases
- Written informed consent form
Exclusion Criteria:
- patients with systemic diseases that may affect retinal or choroidal thickness including diabetes
- patients with history of refractive surgeries, intraocular surgeries or retinal laser treatments
- patients with history of macular, retinal, or optic nerve abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy volunteers
to measure the subfoveal choroidal thickness in healthy volunteers
|
measure subfoveal choroidal thickness using optical coherence tomography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
subfoveal choroidal thickness
Time Frame: up to 4 months
|
Thickness of choroid at the foveal area
|
up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yosanan Yospaiboon, MD, Department of Ophthalmology, Khon Kaen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
September 15, 2015
First Submitted That Met QC Criteria
September 15, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 12, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- HE561056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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