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

Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases

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 Overview

• Status: Recruiting
• Conditions: Lacrimal Duct Obstruction
• Intervention / Treatment: Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization; Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: qin q yu; Phone Number: 18757163724; Email: 18757163724@163.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital of Zhejiang University Hospital
    • Contact: qin qi yu; Phone Number: 18757163724; Email: 18757163724@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperatively 1 week, 1, 2, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperatively 1 week, 1, 2, 3 months, 6 months
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	Postoperatively 1 week, 1, 2, 3 months, 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2018
• Primary Completion (ANTICIPATED): July 7, 2023
• Study Completion (ANTICIPATED): August 7, 2023

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (ACTUAL): June 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Lacrimal Duct Obstruction; Low temperature plasma ablation
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Lacrimal Duct Obstruction
• Other Study ID Numbers: 2018-151

Drug and device information, study documents

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