Chronic DacryocystitisNCT06551766
The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy
A study testing Photosensitive hydrogel and 6-0 absorbable stitches in people with Chronic Dacryocystitis, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Dacryocystitis
- What is being tested?
- Photosensitive hydrogel and 6-0 absorbable stitches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, 200031
Tong Lin, MD, 13585764906, lintongwzmc@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Dacryocystitis
- Being tested
- Photosensitive hydrogel, 6-0 absorbable stitches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photosensitive hydrogelDevice
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 stitchesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Photosensitive hydrogel |
| Suture fixation | Active comparator | The suture is fixed with 6-0 absorbable thread. Receives: Device: 6-0 absorbable stitches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic opening rate
The opening of the anastomosis was observed by nasal endoscopy.
Measured: 6 weeks after surgery
Secondary outcomes (1)
Remission rate of tearing symptoms
The remission of tearing symptoms was assessed by VAS scale
Measured: 2, 6 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DacryocystitisStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551766
- Sponsor's protocol ID
- 2023017
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy for the Anastomosis of Lacrimal Cyst Flap and Nasal Mucoperiosteal Flap
- ClinicalTrials.gov ID
- NCT06551766
- Acronym / sponsor ID
- 2023017
- Conditions
- Chronic Dacryocystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photosensitive hydrogel | Experimental | Device: Photosensitive hydrogelThe 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. |
| Suture fixation | Active comparator | Device: 6-0 absorbable stitchesThe suture is fixed with 6-0 absorbable thread. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photosensitive hydrogelIn the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel. | Device | Photosensitive hydrogel |
| 6-0 absorbable stitchesIn 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. | Device | Suture fixation |
Primary outcome
Anastomotic opening rate
Time frame: 6 weeks after surgery
The opening of the anastomosis was observed by nasal endoscopy.
1 secondary outcome
Remission rate of tearing symptoms
Time frame: 2, 6 and 12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Chronic Dacryocystitis
RecruitingPhase 2
Absorbable Drug-Eluting Lacrimal Sac Stent for Recurrent Chronic Dacryocystitis
Chronic Dacryocystitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photosensitive hydrogel and 6-0 absorbable stitches in people with Chronic Dacryocystitis, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic opening rate (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.