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Correlation between clinical presentations of dry eye and intracorneal inflammation: An In vivo confocal microscopic analysis

Correlation between clinical presentations of dry eye and intracorneal inflammation: An In vivo confocal microscopic analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20250120001
Enrollment
75
Registered
2025-01-20
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Correlation between clinical presentations of dry eye and intracorneal inflammation: An In vivo confocal microscopic analysis Dry eye Intracorneal inflammation In vivo confocal microscopic

Interventions

No dry eye symptoms and ocular surface abrasions (grade 0).,with dry eye symptoms but ocular surface abrasions (grade 0).,with dry eye symptoms and ocular surface abrasions (grade 1).,with dry eye sym
Control,Dry eye 0,Dry eye 1,Dry eye 2,Dry eye 3

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Healthy Thai men or women aged 40-80 years, with no underlying diseases or medication use that can cause dry eye disease. If there are other underlying physical diseases, they must be controllable diseases to be a control group of 15 people. 2. People who were diagnosed with dry eye disease based on symptoms and signs from a clinical eye examination that are consistent with dry eye disease according to the Dry Eye Severity Grading Scheme (Asia Dry Eye Society DEWS II 2017). In the research, volunteers will be divided into groups according to the severity of the disease with abrasions on the eye surface, divided into abrasions of level 0, 1, 2, and 3 or higher (according to the Oxford score), with 15 people per group. Volunteers will undergo corneal staining before joining the research to be assigned to groups. If some groups have enough participants, no more volunteers will be accepted. Volunteers who are diagnosed after the number of participants is reached will not receive compensation from the research. However, they will receive treatment according to the standard of care for dry eye patients at Siriraj Hospital. 3. Volunteers in both the control group and the dry eye group must not have eye diseases and/or a history of eye diseases that affect corneal inflammation that require continuous treatment until the day they join this research, including. 3.1) Chronic eye allergy. 3.2) Corneal ulcers, including herpes simplex. 3.3) Eye injuries. 3.4) Major ocular surgery or cataract surgery within 3 months before joining the research. 3.5) Glaucoma that requires continuous use of eye drops to lower eye pressure. 3.6) Various types of corneal degeneration, such as corneal dystrophy, bullous keratopathy. 4. No history of continuous use of eye medications, except artificial tears, within 3 months before joining the research Both the control and dry eye patients in this study. 5. No systemic inflammatory disease, such as autoimmune disease or septicemia, was found in both the dry eye and control groups. 6. No systemic neuropathy, such as diabetes mellitus, cerebrovascular disease, etc., was found in both the dry eye and control groups.

Exclusion criteria

Exclusion criteria: 1. Severe dry eye disease due to Stevens Johnson syndrome or systemic immune/inflammatory disease. 2. Persistent epithelial defect. 3. Those who have received any type of anti-inflammatory medication, including steroids (eye drops and/or oral medication) within 3 months before. 4. Those who have undergone previous laser refractive surgery. 5. Those who are allergic to local anesthetics or to fluorescein staining of the cornea and conjunctiva 6. Those who are unable to cooperate in the eye examination or the special equipment used for the diagnosis of dry eye disease in this study.

Design outcomes

Primary

MeasureTime frame
Number of inflammatory cells and the density of subcorneal nerves First visit Calculate from confocal microscopy images

Secondary

MeasureTime frame
Compare correlation between the number of inflammatory cells and the density of subcorneal nerves First visit Calculate from confocal microscopy images

Countries

Thailand

Contacts

Public ContactChareenun Chirapapaisan

Faculty of Medicine Siriraj Hospital, Mahidol University

chareenun@gmail.com024198037

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026