search
Back to results

Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia

Primary Purpose

Chalazion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IPL-MGX
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chalazion focused on measuring Chalazion, IPL, Meibomian gland function

Eligibility Criteria

24 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments.

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 Type

Experimental

Arm Label

Recurrent chalazia with IPL-MGX

Arm Description

The patients whose lesions had failed to respond to warm compresses and antibiotic and steroid treatment underwent incision and curettage. One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid. After removal of the ultrasound gel, meibomian gland expression (MGX) was performed with forceps-shaped meibomian gland compressor.

Outcomes

Primary Outcome Measures

Recurrence rate of chalazia
The recurrence rate of the recurrent chalazia

Secondary Outcome Measures

NITBUT
non-invasive tear film breakup time
meibomian expressibility and quality
The expressibility and quality score of the meibum
TMH
tear meniscus height

Full Information

First Posted
September 9, 2021
Last Updated
September 27, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT05070611
Brief Title
Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
Official Title
Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
November 1, 2021 (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
The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.
Detailed Description
We hypothesized that IPL application on the skin adjacent to eyelids after chalazion surgery will result in better meibomian gland function and lower recurrence. To date, it has not been previously reported the outcomes of the use of this technology for the management of chalazions recurrence. The purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chalazion
Keywords
Chalazion, IPL, Meibomian gland function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recurrent chalazia with IPL-MGX
Arm Type
Experimental
Arm Description
The patients whose lesions had failed to respond to warm compresses and antibiotic and steroid treatment underwent incision and curettage. One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid. After removal of the ultrasound gel, meibomian gland expression (MGX) was performed with forceps-shaped meibomian gland compressor.
Intervention Type
Device
Intervention Name(s)
IPL-MGX
Intervention Description
One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid.13 Before treatment, the eyes were protected with opaque goggles and ultrasound gel was applied on the patient's face from tragus to tragus including the nose to conduct the light.
Primary Outcome Measure Information:
Title
Recurrence rate of chalazia
Description
The recurrence rate of the recurrent chalazia
Time Frame
an average of 1 year
Secondary Outcome Measure Information:
Title
NITBUT
Description
non-invasive tear film breakup time
Time Frame
an average of 1 year
Title
meibomian expressibility and quality
Description
The expressibility and quality score of the meibum
Time Frame
an average of 1 year
Title
TMH
Description
tear meniscus height
Time Frame
an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments. 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
jin x ming
Phone
13989455778
Email
18344980413@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhu y rui
Phone
15868805518
Email
zhuyirui001@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
lin lin
Organizational Affiliation
Second Affiliated Hospital of Zhejiang University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhu y rui
Phone
15868805518
Email
zhuyirui001@126.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia

We'll reach out to this number within 24 hrs