The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Dacryocystitis
• Intervention / Treatment: Device: Photosensitive hydrogel; Device: 6-0 absorbable stitches

Detailed Description

After endoscopic dacryocystonasal anastomosis, granulation and/or cicatricial adhesion are the main reasons for surgical failure. How to achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid the proliferation of granulation and cicatricial adhesion is very important for the success of the operation. In this study, "photocoupling reaction" technology was used to achieve seamless integration and strong adhesion of photosensitive hydrogel materials to the wound, and the photohydrogel was applied to suture free adhesion and wound repair of the lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic nasal Dacryocystostomy (En-DCR), and its feasibility, safety and effectiveness were evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200031
    • Recruiting
    • Eye & ENT Hospital of Fudan University
    • Contact: Tong Lin, MD; Phone Number: 13585764906; Email: lintongwzmc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photosensitive hydrogel; 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; In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel.
Active Comparator: Suture fixation; The suture is fixed with 6-0 absorbable thread.	Device: 6-0 absorbable stitches; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anastomotic opening rate	The opening of the anastomosis was observed by nasal endoscopy.	6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission rate of tearing symptoms	The remission of tearing symptoms was assessed by VAS scale	2, 6 and 12 weeks after surgery

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dacryocystitis
• Other Study ID Numbers: 2023017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will publish the data in the form of a paper, and other researchers can obtain the required information with the permission of the principal investigator.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Other researchers can obtain the required information with the permission of the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No