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
1 other identifier
interventional
180
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2018
CompletedFirst Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2023
CompletedJune 29, 2021
June 1, 2021
4.7 years
June 10, 2021
June 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications
Postoperatively 1 week, 1, 2, 3 months, 6 months
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
Postoperatively 1 week, 1, 2, 3 months, 6 months
Study Arms (2)
Low temperature plasma ablation with lacrimal duct catheterization
EXPERIMENTALThe experimental group received low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization
YAG lacrimal duct laser combined with lacrimal duct catheter
PLACEBO COMPARATORControl group received YAG lacrimal duct laser combined with lacrimal duct catheterization
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
lin lin
Second Affiliated Hospital of Zhejiang University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 29, 2021
Study Start
October 10, 2018
Primary Completion
July 7, 2023
Study Completion
August 7, 2023
Last Updated
June 29, 2021
Record last verified: 2021-06