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Trial Title:
Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion
NCT ID:
NCT05512572
Condition:
Chalazion
Conditions: Official terms:
Chalazion
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
IPL
Description:
intense pulsed light
Arm group label:
Experimental group
Intervention type:
Procedure
Intervention name:
Conservative treatment or excision with curettage
Description:
conservative treatment or excision with curettage but without IPL-MGX treatment as a
control
Arm group label:
Control group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Zhejiang University Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
rui 6yi zhu
Phone:
15868805518
Email:
mailto:zhuyirui001@126.com
Investigator:
Last name:
lin lin
Email:
Principal Investigator
Start date:
August 23, 2021
Completion date:
August 23, 2023
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512572
