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

Lacrimal Duct Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943055
• Other study ID #: 2018-151
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: August 7, 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: jin x ming
• Phone: 13989455778
• Email: 18344980413[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ? 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 ? Patients with severe abnormal liver and kidney function and cardiovascular and cerebrovascular diseases In addition to lacrimal duct obstruction, there are other ophthalmic diseases ? Exclude diabetes
• Exclusion of pregnancy, lactation women ? Not willing to participate in research

Related Conditions & MeSH terms

• Lacrimal Duct Obstruction

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University Hospital	Hangzhou

Sponsors (3)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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