Using a special hydrogel for surgery to treat chronic tear duct infections
The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap
This study is testing a special gel used in surgery to see if it can help people with chronic tear duct infections heal better and have fewer problems compared to traditional stitches.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06551766 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a photosensitive hydrogel in a surgical procedure called endoscopic dacryocystorhinostomy to treat chronic dacryocystitis. The hydrogel aims to facilitate suture-free adhesion between the lacrimal cyst and nasal mucoperiosteal flap, potentially improving wound healing and reducing complications. Twenty patients will be randomly assigned to receive either the hydrogel or traditional sutures, with follow-up assessments at 2, 6, and 12 weeks post-surgery to evaluate outcomes and any adverse events. The study focuses on the effectiveness and safety of this innovative approach in preventing surgical failure due to granulation and adhesion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with chronic dacryocystitis and specific obstruction patterns in the lacrimal duct.
Not a fit: Patients with acute dacryocystitis, significant nasal diseases, or prior dacryocystonasal anastomosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced recovery times for patients with chronic dacryocystitis.
How similar studies have performed: While the use of hydrogels in surgical applications is gaining interest, this specific approach appears to be novel and untested in the context of dacryocystitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily participate in this clinical study and sign the informed consent; 2. Gender is not limited, age 18-75 years old; 3. The patient had symptoms and signs of chronic dacryocystitis, and the results of lacrimal passage irrigation suggested that the lower rush and return or upper rush and lower return, accompanied by mucous or purulent discharge reflux; 4. Lacrimal duct angiography suggests nasolacrimal duct obstruction without lacrimal canaliculi and/or duct obstruction. Exclusion Criteria: 1. Age \< 18 or \> 75 years old; 2. Previous history of dacryocystonasal anastomosis; 3. Abnormal coagulation function; 4. Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors; 5. in the acute dacryocystitis attack stage; 6. obvious scar constitution; 7. Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic rhinosinusitis and nasal polyps, acute suppurative rhinosinusitis, severe atrophic rhinitis, and severe deviation of nasal septum; 8. Have serious heart, liver, kidney, lung and other basic diseases, can not tolerate general anesthesia; 9. Distance from the hospital, postoperative review is not convenient; 10. Participated in other clinical trials within the last 3 months; 11. Any medical history that the investigator determines may interfere with the test results or increase the patient's risk.
Where this trial is running
Shanghai
- Eye & ENT Hospital of Fudan University — Shanghai, China (Recruiting)
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.