Ss-octaNCT06091722
Quantitative Assessment of Lid Margin Vascularity Using SS-OCTA
An observational study of Ss-octa and Lid Margin Blood Flow Density, run by Wenzhou Medical University.
Trial summary
To explore an optimized scan technique for the detection of lid margin vasculature Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ss-octa, Lid Margin Blood Flow Density, MGD
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 28 Feb 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MGD or normal patients who could cooperate with dry eye evaluation and SSOCTA examination in the dry eye Clinic of the Eye Hospital of Wenzhou Medical University were enrolled.
Who may be able to join
- The MGD patients were aged >20 years and were diagnosed according to Chinese MGD diagnostic criteria,11 including dry eye symptoms, and at least one of the following signs: (1) poor meibum expressibility or quality; (2) at least one of eyelid margin abnormalities (lid margin irregularity, plugging of the gland orifice, vascular engorgement/telangiectasia, and anterior replacement of the mucocutaneous junction. Normal subjects were defined as adults without any dry eye symptoms and lid margin abnormality.
Who cannot join
- subjects with ocular diseases or conditions known to affect the anatomy of the anterior segment, such as acute ocular inflammation, a history of eyelid surgery, contact lens wear within two weeks, and/or eyelid trauma; (2) subjects with of history of systemic or topical medications that might cause ocular congestion; (3) subjects with severe systemic illness or pregnancy; and (4) subjects who were difficult to cooperate with examination, resulting the obtained images were not sufficiently clear for automatic analysis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quantitative Assessment of Lid Margin Vascularity Using Swept-source Optical Coherence Tomographic Angiography
To explore an optimized scan technique for the detection of lid margin vasculature
Read the detailed description
To investigate whether the SS-OCTA tool has the potential to characterize the lid margin vascularity in MGD patients. The repeatability and validity of OCTA in assessing eyelid margin blood flow density was evaluated。
- Conditions
- Ss-octa, Lid Margin Blood Flow Density, MGD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mild group, the scores of both clinicians were ≤ grade 1 | |
| 2 | Moderate group, one doctor scored grade 2, and the other doctor scored 1~2; | |
| 3 | Moderate group, one doctor scored grade 2, and the other doctor scored 1~2; |
What is being measured
The primary outcome is the main question the study is designed to answer.
LMBFD
Lid margin blood flow density
Measured: Immediately after ssocta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ss-octaStudies 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091722
- Sponsor's protocol ID
- 20230801LMBFD
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Lid Margin Vascularity Using Swept-source Optical Coherence Tomographic Angiography
- ClinicalTrials.gov ID
- NCT06091722
- Acronym / sponsor ID
- 20230801LMBFD
- Conditions
- Ss-octa, Lid Margin Blood Flow Density, MGD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 19 Oct 2023 (actual)
- 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.
To explore an optimized scan technique for the detection of lid margin vasculature
Detailed description
To investigate whether the SS-OCTA tool has the potential to characterize the lid margin vascularity in MGD patients. The repeatability and validity of OCTA in assessing eyelid margin blood flow density was evaluated。
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mild group, the scores of both clinicians were ≤ grade 1 |
| 2 | – | –Moderate group, one doctor scored grade 2, and the other doctor scored 1~2; |
| 3 | – | –Moderate group, one doctor scored grade 2, and the other doctor scored 1~2; |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MGD or normal patients who could cooperate with dry eye evaluation and SSOCTA examination in the dry eye Clinic of the Eye Hospital of Wenzhou Medical University were enrolled.
Key inclusion criteria (1 listed)
- The MGD patients were aged >20 years and were diagnosed according to Chinese MGD diagnostic criteria,11 including dry eye symptoms, and at least one of the following signs: (1) poor meibum expressibility or quality; (2) at least one of eyelid margin abnormalities (lid margin irregularity, plugging of the gland orifice, vascular engorgement/telangiectasia, and anterior replacement of the mucocutaneous junction. Normal subjects were defined as adults without any dry eye symptoms and lid margin abnormality.
Key exclusion criteria (1 listed)
- subjects with ocular diseases or conditions known to affect the anatomy of the anterior segment, such as acute ocular inflammation, a history of eyelid surgery, contact lens wear within two weeks, and/or eyelid trauma; (2) subjects with of history of systemic or topical medications that might cause ocular congestion; (3) subjects with severe systemic illness or pregnancy; and (4) subjects who were difficult to cooperate with examination, resulting the obtained images were not sufficiently clear for automatic analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LMBFD
Time frame: Immediately after ssocta
Lid margin blood flow density
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ss-octa and Lid Margin Blood Flow Density, run by Wenzhou Medical University.
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 1 inclusion and 1 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Man HU (13738069080, 64344308@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LMBFD (time frame: Immediately after ssocta). 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 19 Oct 2023.