Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427629
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-02
Brief Title:
Investigator-initiated Clinical Trial to Observe Conjunctival Goblet Cell Using an Anterior Segment Imaging Device
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 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
Detailed Description:
Conjunctival goblet cells secrete mucin on the ocular surface playing a role in forming the mucin layer of the tear film The mucin layer is crucial for maintaining tear film stability and dysfunction of conjunctival goblet cells can lead to instability of the mucin layer causing problems in the tear film Because various ocular surface diseases stem from tear film instability imaging of conjunctival goblet cells is essential for diagnosing and treating conditions such as dry eye
05 moxifloxacin eye drops are FDA-approved antibiotics belonging to the quinolone class widely used to treat bacterial infections in various ocular diseases Clinically 05 moxifloxacin eye drops are commonly used for purposes such as secondary infection prevention in cases of corneal epithelial defects or perforations caused by ocular surface diseases as well as for prophylaxis prior to various ophthalmic surgeries including cataract surgery
The investigators have previously pioneered non-invasive high-speed high-contrast imaging of conjunctival goblet cells Previous studies have validated the performance and safety of this method by imaging conjunctival goblet cells in mice and rabbit animal models after the instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy Furthermore in this study the investigators plan to conduct a study involving human subjects to apply our developed conjunctival goblet cell imaging technique for the diagnosis and evaluation of treatment outcomes in ocular surface diseases
05 moxifloxacin eye drops are FDA-approved antibiotics belonging to the quinolone class widely used to treat bacterial infections in various ocular diseases Clinically 05 moxifloxacin eye drops are commonly used for purposes such as secondary infection prevention in cases of corneal epithelial defects or perforations caused by ocular surface diseases as well as for prophylaxis prior to various ophthalmic surgeries including cataract surgery
The investigators have previously pioneered non-invasive high-speed high-contrast imaging of conjunctival goblet cells Previous studies have validated the performance and safety of this method by imaging conjunctival goblet cells in mice and rabbit animal models after the instillation of moxifloxacin and illuminating with a 405nm light source using confocal fluorescence microscopy Furthermore in this study the investigators plan to conduct a study involving human subjects to apply our developed conjunctival goblet cell imaging technique for the diagnosis and evaluation of treatment outcomes in ocular surface diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None