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

NCT06427629 | Recruiting

• 1 other identifier: 2311-108-1485
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ocular Surface Disease

Outcome Measures

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

  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

  At the time of imaging

Study Arms (2)

Patients with ocular surface disease

OTHER

Patients diagnosed with dry eye disease, sjogren syndrome, stevens-johnson syndrome, ocular graft versus host disease.

Device: Imaging of conjunctival goblet cell

Patients scheduled for ocular surgery without ocular surface disease

OTHER

Patients without ocular surface disease and scheduled for cataract surgery which requires moxifloxacin administration

Device: Imaging of conjunctival goblet cell

Interventions

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

Patients scheduled for ocular surgery without ocular surface disease; Patients with ocular surface disease

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Changho Yoon

Seoul, 03080, South Korea

RECRUITING

Study Officials

• Chang Ho Yoon, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Ho Yoon, MD PhD

CONTACT

82220724309; ifree7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 24, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

KR (1)