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

NCT ID: NCT04943055

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2023-08-07

Brief Summary

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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

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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

Conditions

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Lacrimal Duct Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low temperature plasma ablation with lacrimal duct catheterization

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

Group Type EXPERIMENTAL

Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization

Intervention Type PROCEDURE

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

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

Group Type PLACEBO_COMPARATOR

YAG lacrimal duct laser combined with lacrimal duct catheter

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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lin lin

Role: STUDY_CHAIR

Second Affiliated Hospital of Zhejiang University Hospital

Locations

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Second Affiliated Hospital of Zhejiang University Hospital

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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jin x ming

Role: CONTACT

13989455778

qin q yu

Role: CONTACT

18757163724

Facility Contacts

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qin qi yu

Role: primary

18757163724

Other Identifiers

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2018-151

Identifier Type: -

Identifier Source: org_study_id

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