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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04943055
Collaborator
Zhejiang Provincial People's Hospital (Other), The First Affiliated Hospital with Nanjing Medical University (Other)
180
1
2
57.9
3.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
  • Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
Actual Study Start Date :
Oct 10, 2018
Anticipated Primary Completion Date :
Jul 7, 2023
Anticipated Study Completion Date :
Aug 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low temperature plasma ablation with lacrimal duct catheterization

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

Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
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.

Placebo Comparator: YAG lacrimal duct laser combined with lacrimal duct catheter

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

Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter
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.

Outcome Measures

Primary Outcome Measures

  1. Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering [Postoperatively 1 week, 1, 2, 3 months, 6 months]

    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

  1. Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications [Postoperatively 1 week, 1, 2, 3 months, 6 months]

    The complications of laser or plasma treatment involve abnormal tear secretion, acute and chronic purulent dacryocystitis, sepsis, false passage formation, epistaxis, and subcutaneous emphysema

  2. Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score [Postoperatively 1 week, 1, 2, 3 months, 6 months]

    The VAS pain grade was recorded on a 0-10 scale, with 0 being no pain and 10 being the most intense pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital of Zhejiang University Hospital Hangzhou China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Zhejiang Provincial People's Hospital
  • The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: lin lin, Second Affiliated Hospital of Zhejiang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04943055
Other Study ID Numbers:
  • 2018-151
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021