Clinical trial NCT04943055: Low Temperature Plasma Ablation Combined Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive
Official title: Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lacrimal Duct Obstruction
Keywords: Lacrimal Duct Obstruction
Low temperature plasma ablation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2021-06-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
timeFrame: Postoperatively 1 week, 1, 2, 3 months, 6 months
Secondary outcomes:
measure: Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications
timeFrame: Postoperatively 1 week, 1, 2, 3 months, 6 months
measure: Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
timeFrame: Postoperatively 1 week, 1, 2, 3 months, 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University Hospital
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University Hospital
name: lin lin
role: STUDY_CHAIR
References: