Status:
COMPLETED
Safety and Efficacy of Thermosensitive Hydroxybutyl Chitosan and 5-fluorouracil Assisted Endoscopic Dacryocystorhinostomy in the Treatment of Chronic Dacryocystitis
Lead Sponsor:
Tianjin Medical University Eye Hospital
Conditions:
Dacryocystorhinostomy
Hydroxybutyl Chitosan
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter time, less postoperative bleeding, faster recovery, and no skin scars. However, the success rate of En-DCR...
Detailed Description
Endoscopic dacryocystorhinostomy (En-DCR) has the advantages of less surgical trauma, shorter time, less postoperative bleeding, faster recovery, and no skin scars. However, the success rate of En-DCR...
Eligibility Criteria
Inclusion
- Voluntary and able to sign an informed consent form
- Age ≥18 years
- Diagnosed with chronic dacryocystitis
- Willing and able to complete all planned visits and evaluations
Exclusion
- Those who do not meet the inclusion criteria;
- Those who are allergic to hydroxybutyl chitosan and 5-fluorouracil;
- Patients suffering from blepharitis, hordeolum, blepharitis, ectropion, keratitis, lacrimal tumor and other external eye, ocular surface and other lacrimal diseases within three months, or those who have received eye surgery;
- Patients with chronic dacryocystitis and a history of lacrimal canal placement;
- Patients with history of lacrimal duct surgery and lacrimal duct fistula;
- Patients who have used glucocorticoid sprays within three months.
- Those who have had a history of facial trauma (eyelid trauma, nasal trauma, etc.) or have undergone facial surgery within three months;
- Abnormal nasal cavity or nasal diseases (nasal polyps, nasal tumors, turbinate hypertrophy, nasal bone fracture, etc.) within three months or those who have undergone nasal surgery;
- Patients with epiphora caused by other reasons such as facial paralysis or severe eyelid laxity;
- Those who suffer from autoimmune diseases, bleeding diseases, renal insufficiency dialysis treatment and other serious systemic diseases
- Patients with blisters or herpes zoster;
- Those with more serious skin diseases such as acne, rosacea or scar constitution;
- According to the investigator's judgment, it may interfere with Test results or medical history, personal history and allergy history that increase the risk of patients;
- Those who have participated in clinical trials of other drugs within the last 3 months;
- Those who cannot be followed up regularly or who cannot cooperate with the investigator.
Key Trial Info
Start Date :
December 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06175676
Start Date
December 3 2021
End Date
December 3 2023
Last Update
December 19 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Limin Zhu
Tianjin, China