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

Zhejiang University

Status: Unknown

Conditions: Lacrimal Duct Obstruction

Treatments: Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization; Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT04943055

2018-151

Details and patient eligibility

About

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

Full 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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Low temperature plasma ablation with lacrimal duct catheterization

Experimental group

Description:

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

Treatment:

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

YAG lacrimal duct laser combined with lacrimal duct catheter

Placebo Comparator group

Description:

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

Treatment:

Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter