The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

NCT06551766 | Recruiting DMC

• 1 other identifier: 2023017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

Conditions

Chronic Dacryocystitis

Outcome Measures

Primary Outcomes (1)

• Anastomotic opening rate

  The opening of the anastomosis was observed by nasal endoscopy.

  6 weeks after surgery

Secondary Outcomes (1)

• Remission rate of tearing symptoms

  2, 6 and 12 weeks after surgery

Study Arms (2)

Photosensitive hydrogel

EXPERIMENTAL

The photosensitive hydrogel is composed of tetra-armed poly(ethylene glycol) (4aPEGNB)and methacrylate-modified hyaluronic acid (HAMA).The hydrogel can be rapidly photocured under light induction at 395nm.

Device: Photosensitive hydrogel

Suture fixation

ACTIVE COMPARATOR

The suture is fixed with 6-0 absorbable thread.

Device: 6-0 absorbable stitches

Interventions

Photosensitive hydrogel DEVICE

In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel.

Photosensitive hydrogel

6-0 absorbable stitches DEVICE

In the suture fixation group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by two stitches using 6-0 absorbable wire.

Suture fixation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study and sign the informed consent;
• Gender is not limited, age 18-75 years old;
• 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;
• Lacrimal duct angiography suggests nasolacrimal duct obstruction without lacrimal canaliculi and/or duct obstruction.

You may not qualify if:

• Age \< 18 or \> 75 years old;
• Previous history of dacryocystonasal anastomosis;
• Abnormal coagulation function;
• Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors;
• in the acute dacryocystitis attack stage;
• obvious scar constitution;
• 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;
• Have serious heart, liver, kidney, lung and other basic diseases, can not tolerate general anesthesia;
• Distance from the hospital, postoperative review is not convenient;
• Participated in other clinical trials within the last 3 months;
• Any medical history that the investigator determines may interfere with the test results or increase the patient's risk.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year
• Access Criteria: Other researchers can obtain the required information with the permission of the principal investigator.

Locations

CN (1)