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Low Temperature Plasma Ablation Combined Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive

Primary Purpose

Lacrimal Duct Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
YAG lacrimal duct laser combined with lacrimal duct catheter
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacrimal Duct Obstruction focused on measuring Lacrimal Duct Obstruction, Low temperature plasma ablation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ① sign the informed consent for this study Voluntarily

    • ≥18 years old and < 70 years old (3) Single lacrimal tract obstruction was included in the study

      • no purulent secretion of lacrimal passage

Exclusion Criteria:

  • Patients who meet any of the following criteria will not be eligible for inclusion in this study:

    • Have a history of lacrimal duct surgery, including lacrimal duct catheterization, laser lacrimal duct plasty, etc

      • Have a history of allergy to hormones and antibiotics

        • congenital lacrimal duct malformation

          • nasal trauma and deformation ⑤ Patients with severe abnormal liver and kidney function and cardiovascular and cerebrovascular diseases In addition to lacrimal duct obstruction, there are other ophthalmic diseases ⑦ Exclude diabetes

            • Exclusion of pregnancy, lactation women ⑨ Not willing to participate in research

Sites / Locations

  • Second Affiliated Hospital of Zhejiang University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low temperature plasma ablation with lacrimal duct catheterization

YAG lacrimal duct laser combined with lacrimal duct catheter

Arm Description

The experimental group received low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization

Control group received YAG lacrimal duct laser combined with lacrimal duct catheterization

Outcomes

Primary Outcome Measures

Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
The degree of watering was evaluated and classified according to the following clinical symptoms: 1 = no epiphora, 2 = minimal epiphora outdoors but only with wind or cold, 3 = troublesome epiphora outdoors but not indoors, 4 = epiphora indoors and outdoors

Secondary Outcome Measures

Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications
The complications of laser or plasma treatment involve abnormal tear secretion, acute and chronic purulent dacryocystitis, sepsis, false passage formation, epistaxis, and subcutaneous emphysema
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
The VAS pain grade was recorded on a 0-10 scale, with 0 being no pain and 10 being the most intense pain

Full Information

First Posted
June 10, 2021
Last Updated
June 27, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04943055
Brief Title
Low Temperature Plasma Ablation Combined Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive
Official Title
Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 7, 2023 (Anticipated)
Study Completion Date
August 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the clinical effects of low temperature plasma ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheterization in the treatment of lacrimal duct obstruction
Detailed Description
Low-temperature plasma technology has developed rapidly in recent decades and is now widely used in ophthalmology, otolaryngology, orthopedics, urology and other fields .The low-temperature plasma surgery system relies on a 100kHz radio frequency electric field to excite normal saline (0.9% NaCl) to generate plasma energy, and relies on a 50-100 μm plasma layer generated at the front of the plasma knife to perform precise cutting, ablation and hemostaxy. But the application of this technique in the field of lacrimal duct still needs the accumulation of clinical experience.This study was aimed to compare the clinical effects of low temperature plasma ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheterization in the treatment of lacrimal duct obstruction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacrimal Duct Obstruction
Keywords
Lacrimal Duct Obstruction, Low temperature plasma ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low temperature plasma ablation with lacrimal duct catheterization
Arm Type
Experimental
Arm Description
The experimental group received low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
Arm Title
YAG lacrimal duct laser combined with lacrimal duct catheter
Arm Type
Placebo Comparator
Arm Description
Control group received YAG lacrimal duct laser combined with lacrimal duct catheterization
Intervention Type
Procedure
Intervention Name(s)
Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
Intervention Description
The operation used a tear point dilator to expand the patient's upper and lower tear points, YAG laser/low-temperature plasma knife was used to clear the obstructed site of the patient, and normal saline was used to rinse to ensure the patency of the lacrimal passage. The silicone lacrimal duct drainage tube was selected to put the lacrimal duct drainage tube in the upper and lower lacrimal dots of the patient, and the metal probe was removed after using a crochet, and the drainage tube was moderately pulled upward from the center of the upper and lower lacrimal dots to facilitate the smooth passage of the drainage tube through the whole lacrimal duct and achieve the purpose of dredging the blocked site again. Adjust the length of the drainage tube in the nasal vestibule and leave it in the nasal cavity.
Intervention Type
Procedure
Intervention Name(s)
YAG lacrimal duct laser combined with lacrimal duct catheter
Intervention Description
The operation used a tear point dilator to expand the patient's upper and lower tear points, YAG laser/low-temperature plasma knife was used to clear the obstructed site of the patient, and normal saline was used to rinse to ensure the patency of the lacrimal passage. The silicone lacrimal duct drainage tube was selected to put the lacrimal duct drainage tube in the upper and lower lacrimal dots of the patient, and the metal probe was removed after using a crochet, and the drainage tube was moderately pulled upward from the center of the upper and lower lacrimal dots to facilitate the smooth passage of the drainage tube through the whole lacrimal duct and achieve the purpose of dredging the blocked site again. Adjust the length of the drainage tube in the nasal vestibule and leave it in the nasal cavity.
Primary Outcome Measure Information:
Title
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
Description
The degree of watering was evaluated and classified according to the following clinical symptoms: 1 = no epiphora, 2 = minimal epiphora outdoors but only with wind or cold, 3 = troublesome epiphora outdoors but not indoors, 4 = epiphora indoors and outdoors
Time Frame
Postoperatively 1 week, 1, 2, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications
Description
The complications of laser or plasma treatment involve abnormal tear secretion, acute and chronic purulent dacryocystitis, sepsis, false passage formation, epistaxis, and subcutaneous emphysema
Time Frame
Postoperatively 1 week, 1, 2, 3 months, 6 months
Title
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
Description
The VAS pain grade was recorded on a 0-10 scale, with 0 being no pain and 10 being the most intense pain
Time Frame
Postoperatively 1 week, 1, 2, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ① sign the informed consent for this study Voluntarily ≥18 years old and < 70 years old (3) Single lacrimal tract obstruction was included in the study no purulent secretion of lacrimal passage Exclusion Criteria: Patients who meet any of the following criteria will not be eligible for inclusion in this study: Have a history of lacrimal duct surgery, including lacrimal duct catheterization, laser lacrimal duct plasty, etc Have a history of allergy to hormones and antibiotics congenital lacrimal duct malformation nasal trauma and deformation ⑤ Patients with severe abnormal liver and kidney function and cardiovascular and cerebrovascular diseases In addition to lacrimal duct obstruction, there are other ophthalmic diseases ⑦ Exclude diabetes Exclusion of pregnancy, lactation women ⑨ Not willing to participate in research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jin x ming
Phone
13989455778
Email
18344980413@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
qin q yu
Phone
18757163724
Email
18757163724@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lin lin
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qin qi yu
Phone
18757163724
Email
18757163724@163.com

12. IPD Sharing Statement

Learn more about this trial

Low Temperature Plasma Ablation Combined Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive

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