HealthyNCT02551601
Subfoveal Choroidal Thickness in Thai Population
An observational study of Healthy, run by Khon Kaen University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- measure subfoveal choroidal thickness
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers, age 18 years or above, no ocular diseases
Who may be able to join
- Age 18 years or above
- Healthy subjects
- No ocular diseases
- Written informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- measure subfoveal choroidal thickness
- Keywords
- subfoveal choroidal thickness, optical coherence tomography, enhanced depth imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure subfoveal choroidal thicknessOther
measure subfoveal choroidal thickness using optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | to measure the subfoveal choroidal thickness in healthy volunteers Receives: Other: measure subfoveal choroidal thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
subfoveal choroidal thickness
Thickness of choroid at the foveal area
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018
- Study completionAug 2018
Why it stopped: No new participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosanan Yospaiboon, Khon Kaen University
- Investigators
- Yosanan Yospaiboon, MD, Principal investigator, Department of Ophthalmology, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551601
- Sponsor's protocol ID
- HE561056
- Status last verified
- Aug 2019
- First submitted
- 15 Sep 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subfoveal Choroidal Thickness in Thai Population
- ClinicalTrials.gov ID
- NCT02551601
- Acronym / sponsor ID
- HE561056
- Conditions
- Healthy
- Keywords
- subfoveal choroidal thickness, optical coherence tomography, enhanced depth imaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No new participants
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: measure subfoveal choroidal thicknessto measure the subfoveal choroidal thickness in healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers, age 18 years or above, no ocular diseases
Key inclusion criteria (4 listed)
- Age 18 years or above
- Healthy subjects
- No ocular diseases
- Written informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure subfoveal choroidal thicknessmeasure subfoveal choroidal thickness using optical coherence tomography | Other | Healthy volunteers |
Primary outcome
subfoveal choroidal thickness
Time frame: up to 4 months
Thickness of choroid at the foveal area
Results and safety
The study was stopped early (reason given: No new participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yosanan Yospaiboon, MD principal investigator
Department of Ophthalmology, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No new participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subfoveal choroidal thickness (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.