Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
Primary Purpose
Chalazion
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IPL
Conservative treatment or excision with curettage
Sponsored by
About this trial
This is an interventional treatment trial for Chalazion
Eligibility Criteria
Inclusion Criteria:
- Patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications
Exclusion Criteria:
- (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.
Sites / Locations
- Second Affiliated Hospital of Zhejiang University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Receiving IPL-MGD treatment.
Another set of age, sex and diagnosis matched consecutive cases of chalazion, who received conservative treatment or excision with curettage but without IPL-MGX treatment as a control (Non-IPL group).
Outcomes
Primary Outcome Measures
Recurrence rate of chalazia
The recurrence of the chalazia
Secondary Outcome Measures
Full Information
NCT ID
NCT05512572
First Posted
August 21, 2022
Last Updated
September 17, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05512572
Brief Title
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
Official Title
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
August 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Study method: This test screened the subjects first, and proposed to include 50 subjects with primary or recurrent eyelid plate gland cysts without obvious surgical indications. All subjects underwent three strong pulsed light therapy combined with eyelid plate gland massage, treatment of local anesthesia eye drops, and metal pads were placed in conjunctival sac protection. Eye protection, using the M22 strong pulsed light small optical treatment head of the medical company, energy selection 14-16J/cm2, laser position is selected on the upper and lower eyelids, 3mm away from the root of the eyelashes. Each interval is 3 weeks. Eye-related examinations were performed before treatment and 3 times after treatment. The evaluation content included: ocular surface, slit lamp observation, anterior segment photography, intraocular pressure, vision, corneal fluorescein staining, tear film rupture time, eyelid plate gland evaluation, eyelid plate gland cyst relief, eyelid plate gland cyst recurrence rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Receiving IPL-MGD treatment.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Another set of age, sex and diagnosis matched consecutive cases of chalazion, who received conservative treatment or excision with curettage but without IPL-MGX treatment as a control (Non-IPL group).
Intervention Type
Device
Intervention Name(s)
IPL
Intervention Description
intense pulsed light
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment or excision with curettage
Intervention Description
conservative treatment or excision with curettage but without IPL-MGX treatment as a control
Primary Outcome Measure Information:
Title
Recurrence rate of chalazia
Description
The recurrence of the chalazia
Time Frame
An average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications
Exclusion Criteria:
(1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or MGD; (4) skin cancer or pigmented lesion in the treatment zone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ming xiu jin
Phone
13989455778
Email
mailto:18344980413@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
rui yi zhu
Phone
15868805518
Email
mailto:zhuyirui001@126.com
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rui 6yi zhu
Phone
15868805518
Email
mailto:zhuyirui001@126.com
First Name & Middle Initial & Last Name & Degree
lin lin
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
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