Status:
UNKNOWN
Morphological Analysis of Meibomian Glands
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Meibomian Gland Dysfunction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
An automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal int...
Detailed Description
Meibomian glands are essential for maintaining ocular surface health and integrity secrete various lipid components to forms a lipid layer to prevent excessive tear evaporation. Functional disorders o...
Eligibility Criteria
Inclusion
- General
- Age from 18 to 70 years.
- Patients and healthy volunteers who are willing and capable to participate in this clinical study with signed Informed Consent Form.
- Inclusion Criteria of patients:
- Clinical diagnosis of MGD: The diagnosis of MGD was based on an altered quality of expressed secretions and/or decreased or absent expression.
- Patients without ≥2/3 Meibomian glands atrophy.
- Fitzpatrick skin type 1-4.
- Inclusion Criteria of healthy volunteers:
- Negative history or condition of ocular or systemic illness based on evaluation by a research physician.
- General
Exclusion
- Patients and healthy volunteers with ocular allergies, trauma, contact lens wear, continuous medications usage such as tretinoin, isotretinoin, antidepressant medications, photosensitive drugs, glucocorticoids and immunomodulators, or have used them within one month.
- Patients and healthy volunteers who have a history of ocular surface surgery.
- Patients and healthy volunteers who have active ocular surface infection or have suffered from ocular surface infection within one month.
- Patients and healthy volunteers who have endophthalmitis or a medical history of endophthalmitis.
- Patients and healthy volunteers who have a medical history of viral keratitis infection.
- Women who are pregnant, planning to become pregnant during the course of the study or breast-feeding (women of child-bearing age will be asked by the physician).
- Meibography images were blurred or with obvious tarsus folds, incomplete exposure and large hyperreflective area.
- Patients and healthy volunteers who are not suitable for the trial as determined by investigators.
- Exclusion Criteria of patients:
- Patients have abnormalities of ocular surface function or eyelid function, or presence of precancerous lesions, cancer or pigmentation in the eyelid area.
- Patients who have plans to receive ocular surgeries (e.g., cataract, myopic refractive surgery) within 6 months.
- Patients who have been treated with lacrimal punctum embolization within one month.
- Patients with disease that could lead to ADDE, such as Sjogren syndrome and a lacrimal gland abnormality.
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04052841
Start Date
October 12 2020
End Date
December 1 2023
Last Update
April 25 2023
Active Locations (2)
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1
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
2
Deng Yuqing
Guangzhou, China, 510060