Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorSeoul National University Hospital

About this trial

Conjunctival goblet cells secrete mucin, vital for tear film stability. Dysfunction can cause tear film issues and lead to diseases like dry eye. Imaging these cells is crucial for diagnosis and treatment. 0.5% moxifloxacin eye drops, an FDA-approved antibiotic, are used to treat bacterial eye infections and prevent infections before surgeries. The investigators developed a non-invasive imaging method for goblet cells, validated in animals, and now plan to test it in humans for diagnosing and treating ocular surface diseases.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients aged 19 years or older.

Patients who are currently using or scheduled to use 0.5% moxifloxacin eye drops for ophthalmic surgery (control group) or for ocular surface diseases (patient group: dry eye, Sjogren's syndrome, Stevens-Johnson syndrome, graft versus host disease).

Patients who have agreed to understand and comply with the clinical trial protocol's plans for medical examinations and follow-up observations.

Disqualifiers

Pregnant or planning to become pregnant, and lactating women.

Patients with intellectual disabilities and other psychiatric disorders who, at the discretion of the investigator, are deemed ineligible for participation in the clinical trial.

Patients with hypersensitivity reactions to 0.5% moxifloxacin eye drops, or patients for whom administration is contraindicated.

Patients for whom participation in the study is deemed impractical based on the judgment of other medical staff and neutral observers (excluding specified selection/exclusion criteria, based on medical reasons, ethical considerations, low compliance, and understanding of the study).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imaging of conjunctival goblet cell

    Device

    After instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy, conjunctival goblet cell imaging will be performed in patients with ocular surface disease and patients scheduled for ocular surgery without ocular surface disease

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Patients with ocular surface diseaseOther 1 intervention
Group B: Patients scheduled for ocular surgery without ocular surface diseaseOther 1 intervention

Trial outcomes

Primary outcomes

1

Association between conjunctival goblet cell density and severity of dry eye

Severity of dry eye will be assessed based on tear break up time and corneal punctate erosion score

Time frame
At the time of imaging

Secondary outcomes

1

Difference of conjunctival goblet cell density according to disease and additional parameters related with ocular surface disease

Conjunctival punctate erosion score (NEI scale, 0-15), schirmer test (mm), matrix metalloproteinase 9 assay (negative/trace/positive/strong positive), ocular surface disease index (0-100 score) will be assessed as additional parameters.

Time frame
At the time of imaging

Other outcomes

Sponsors and contacts

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