HealthyNCT00926549
Ocular Imaging With Spectral Domain Optical Coherence Tomography
A study testing Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG) in people with Healthy and Myopia, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Myopia, Hypermetropia
- What is being tested?
- Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Sep 2009
- Phase
- Interventional
- 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 16 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- normal eyes
- myopic eyes
- hypermetropic eyes
Who cannot join
- systemic illness
- cataract
- previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, 135-720
Sung Soo Kim, MD, PhD, 82-2-2019-3443, semekim@naver.com
Won Kyung Song, MD, 82-2-2228-3591, songwk@yuhs.ac
About this study
Official title: Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography
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.
Read the detailed 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.
- Conditions
- Healthy, Myopia, Hypermetropia
- Being tested
- Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)
- Keywords
- spectral domain-OCT, macular thickness, myopia, hypermetropia, normal
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)Device
Also called Cirrus™ HD-OCT, Carl Zeiss Meditec AG
macular cube scanning
| Study group | Role | What they receive |
|---|---|---|
| spectral domain-OCT | Experimental | Spectral domain-OCT scanning performed. Receives: Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular retinal thickness and volume
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Sung Soo Kim, MD, PhD, Principal investigator, Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926549
- Sponsor's protocol ID
- 3-2008-0048
- Status last verified
- Jun 2009
- First submitted
- 6 May 2009
- Last updated
- 23 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior and Anterior Ocular Imaging With Spectral Domain Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT00926549
- Acronym / sponsor ID
- 3-2008-0048
- Conditions
- Healthy, Myopia, Hypermetropia
- Keywords
- spectral domain-OCT, macular thickness, myopia, hypermetropia, normal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 23 Jun 2009 (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 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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spectral domain-OCT | Experimental | Device: Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)Spectral domain-OCT scanning performed. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- normal eyes
- myopic eyes
- hypermetropic eyes
Key exclusion criteria (3 listed)
- systemic illness
- cataract
- previous ocular trauma or surgery(other than cataract surgery or refractive surgeries)
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 |
|---|---|---|
| Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG)Also: Cirrus™ HD-OCT, Carl Zeiss Meditec AGmacular cube scanning | Device | spectral domain-OCT |
Primary outcome
macular retinal thickness and volume
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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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.
Sung Soo Kim, MD, PhD principal investigator
Department of Ophthalmology, Yonsei University College of Medicine, Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral domain-OCT (Cirrus™ HD-OCT, Carl Zeiss Meditec AG) in people with Healthy and Myopia, run by Yonsei University at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Jun 2009. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Soo Kim, MD, PhD (82-2-2019-3443, semekim@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
macular retinal thickness and volume (time frame: 3 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 23 Jun 2009.