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NCT Number: NCT06551766

The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

Location status: Recruiting

Location contact

Tong Lin, MD

CONTACT

[email protected]

13585764906

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Anastomotic opening rate

    Time frame: 6 weeks after surgery

    The opening of the anastomosis was observed by nasal endoscopy.

Secondary outcomes

  1. Remission rate of tearing symptoms

    Time frame: 2, 6 and 12 weeks after surgery

    The remission of tearing symptoms was assessed by VAS scale

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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