NCT06091722

Brief Summary

To explore an optimized scan technique for the detection of lid margin vasculature

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 15, 2023

Last Update Submit

October 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • LMBFD

    Lid margin blood flow density

    Immediately after ssocta

Study Arms (3)

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;

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • (1) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 19, 2023

Study Start

October 20, 2023

Primary Completion

December 1, 2023

Study Completion

February 28, 2024

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share