Actively Recruiting
Investigator-initiated Exploratory Clinical Trial to Observe Conjunctival Goblet Cell Density Using an Anterior Segment Imaging Device in Patients With Ocular Surface Disease and Patients Scheduled for Ocular Surgery Without Ocular Surface Disease
Led by Seoul National University Hospital · Updated on 2024-06-20
148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a non-invasive imaging method to observe conjunctival goblet cells, which produce mucin essential for maintaining tear film stability on the eye's surface. Dysfunction of these cells can cause tear film problems leading to ocular surface diseases like dry eye. The study aims to apply this imaging technique in humans to help diagnose and evaluate treatment outcomes for these conditions. The study involves imaging conjunctival goblet cells after applying 0.5% moxifloxacin eye drops, an FDA-approved antibiotic used to treat bacterial eye infections and prevent infections during eye surgeries. Imaging is performed using a 405nm light source and confocal fluorescence microscopy on patients with ocular surface diseases and patients scheduled for cataract surgery without such diseases. Participants will undergo conjunctival goblet cell imaging and assessments related to their eye conditions. Researchers will measure the association between goblet cell density and dry eye severity, along with differences in cell density across diseases. The study includes follow-up observations and aims to gather detailed data for diagnosis and treatment evaluation. Participation lasts through the imaging and assessment phases.
CONDITIONS
Brief Title
Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 19 years or older
- Patients currently using or scheduled to use 0.5% moxifloxacin eye drops for ophthalmic surgery or ocular surface diseases such as dry eye, Sjogren's syndrome, Stevens-Johnson syndrome, or graft versus host disease
- Patients who agree to follow the clinical trial protocol for medical examinations and follow-up observations
You will not qualify if you...
- Pregnant, planning to become pregnant, or breastfeeding women
- Patients with intellectual disabilities or psychiatric disorders deemed ineligible by the investigator
- Patients with hypersensitivity or contraindications to 0.5% moxifloxacin eye drops
- Patients considered impractical for study participation due to medical, ethical, compliance, or understanding reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the time of imaging
Participants undergo non-invasive imaging of conjunctival goblet cells after instillation of moxifloxacin eye drops using a 405nm light source with confocal fluorescence microscopy.
1 imaging visit (in-person)
Duration - Follow-up as per clinical protocol
Participants are observed for follow-up assessments related to ocular surface disease and treatment outcomes.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Changho Yoon
Seoul, South Korea, 03080
Actively Recruiting
Research Team
C
Chang Ho Yoon, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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