Lacrimal Duct ObstructionNCT04943055
Low Temperature Plasma Ablation Combined Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive
A study testing Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheter in people with Lacrimal Duct Obstruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2018to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou
qin qi yu, 18757163724, 18757163724@163.com
About this study
Official title: Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
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
Read the 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
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization, YAG lacrimal duct laser combined with lacrimal duct catheter
- Keywords
- Lacrimal Duct Obstruction, Low temperature plasma ablation
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterizationProcedure or surgery
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 catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Low temperature plasma ablation with lacrimal duct catheterization | Experimental | The experimental group received low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization Receives: Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization |
| YAG lacrimal duct laser combined with lacrimal duct catheter | Placebo comparator | Control group received YAG lacrimal duct laser combined with lacrimal duct catheterization Receives: Procedure: YAG lacrimal duct laser combined with lacrimal duct catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The complications of laser or plasma treatment involve abnormal tear secretion, acute and chronic purulent dacryocystitis, sepsis, false passage formation, epistaxis, and subcutaneous emphysema
Measured: Postoperatively 1 week, 1, 2, 3 months, 6 months
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
The VAS pain grade was recorded on a 0-10 scale, with 0 being no pain and 10 being the most intense pain
Measured: Postoperatively 1 week, 1, 2, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start10 Oct 2018
- Primary completion7 Jul 2023 (estimated)
- Study completion7 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- lin lin, Study chair, Second Affiliated Hospital of Zhejiang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943055
- Sponsor's protocol ID
- 2018-151
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Study of Low Temperature Plasma Ablation Combined With Lacrimal Duct Catheterization in the Treatment of Lacrimal Duct Obstructive Diseases
- ClinicalTrials.gov ID
- NCT04943055
- Acronym / sponsor ID
- 2018-151
- Conditions
- Lacrimal Duct Obstruction
- Keywords
- Lacrimal Duct Obstruction, Low temperature plasma ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 7 Jul 2023 (estimated)
- Study completion
- 7 Aug 2023 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low temperature plasma ablation with lacrimal duct catheterization | Experimental | Procedure: Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterizationThe 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 comparator | Procedure: YAG lacrimal duct laser combined with lacrimal duct catheterControl group received YAG lacrimal duct laser combined with lacrimal duct catheterization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ① sign the informed consent for this study Voluntarily
Key exclusion criteria (6 listed)
- Patients who meet any of the following criteria will not be eligible for inclusion in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterizationThe 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. | Procedure or surgery | Low temperature plasma ablation with lacrimal duct catheterization |
| YAG lacrimal duct laser combined with lacrimal duct catheterThe 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. | Procedure or surgery | YAG lacrimal duct laser combined with lacrimal duct catheter |
Primary outcome
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering
Time frame: Postoperatively 1 week, 1, 2, 3 months, 6 months
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
2 secondary outcomes
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of intraoperative complications
Time frame: Postoperatively 1 week, 1, 2, 3 months, 6 months
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of pain score
Time frame: Postoperatively 1 week, 1, 2, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lin lin study chair
Second Affiliated Hospital of Zhejiang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization and YAG lacrimal duct laser combined with lacrimal duct catheter in people with Lacrimal Duct Obstruction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jin x ming (13989455778, 18344980413@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between 1 week, 1, 2, 3 months and 6 months postoperatively of degree of watering (time frame: Postoperatively 1 week, 1, 2, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.