Imaging conjunctival goblet cells to improve diagnosis of eye diseases
Investigator-initiated Exploratory Clinical Trial to Observe Conjunctival Goblet Cell Density Using an Anterior Segment Imaging Device in Patients With Ocular Surface Disease (ODS) and Patients Scheduled for Ocular Surgery Without OSD
This study is testing a new imaging technique to see if it can help doctors better diagnose eye problems by looking at special cells in the eye of adults using certain eye drops.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06427629 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to utilize a non-invasive imaging technique to observe conjunctival goblet cells, which are essential for maintaining tear film stability. The study will involve adult patients who are using or scheduled to use 0.5% moxifloxacin eye drops, either for ophthalmic surgery or for treating ocular surface diseases like dry eye. The investigators have previously validated this imaging method in animal models and are now applying it to human subjects to enhance the diagnosis and treatment of ocular surface diseases. The trial will assess the effectiveness of this imaging approach in identifying goblet cell dysfunction.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 years or older who are using or scheduled to use 0.5% moxifloxacin eye drops for ocular surface diseases or ophthalmic surgery.
Not a fit: Patients who are pregnant, lactating, or have hypersensitivity to moxifloxacin will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for ocular surface diseases, potentially enhancing treatment outcomes for patients.
How similar studies have performed: While this imaging technique has been validated in animal studies, its application in human subjects represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
Seoul
- Changho Yoon — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Chang Ho Yoon, MD PhD — Seoul National University Hospital
- Study coordinator: Chang Ho Yoon, MD PhD
- Email: ifree7@gmail.com
- Phone: 82220724309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.