Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia

September 27, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recurrent chalazia with IPL-MGX
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.
Device: IPL-MGX
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of chalazia
Time Frame: an average of 1 year
The recurrence rate of the recurrent chalazia
an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NITBUT
Time Frame: an average of 1 year
non-invasive tear film breakup time
an average of 1 year
meibomian expressibility and quality
Time Frame: an average of 1 year
The expressibility and quality score of the meibum
an average of 1 year
TMH
Time Frame: an average of 1 year
tear meniscus height
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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