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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04943055
Enrollment
180
Registered
2021-06-29
Start date
2018-10-10
Completion date
2023-08-07
Last updated
2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lacrimal Duct Obstruction

Keywords

Lacrimal Duct Obstruction, Low temperature plasma ablation

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

Interventions

PROCEDURELow 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.

PROCEDUREYAG 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of wateringPostoperatively 1 week, 1, 2, 3 months, 6 monthsThe 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

Secondary

MeasureTime frameDescription
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complicationsPostoperatively 1 week, 1, 2, 3 months, 6 monthsThe complications of laser or plasma treatment involve abnormal tear secretion, acute and chronic purulent dacryocystitis, sepsis, false passage formation, epistaxis, and subcutaneous emphysema
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain scorePostoperatively 1 week, 1, 2, 3 months, 6 monthsThe VAS pain grade was recorded on a 0-10 scale, with 0 being no pain and 10 being the most intense pain

Countries

China

Contacts

Primary Contactjin x ming
18344980413@qq.com13989455778
Backup Contactqin q yu
18757163724@163.com18757163724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026