Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05070611

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chalazion	Device: IPL-MGX	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Intense Pulsed Light in the Treatment of Recurrent Chalazia

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recurrence rate of chalazia [an average of 1 year]
The recurrence rate of the recurrent chalazia

Secondary Outcome Measures

NITBUT [an average of 1 year]
non-invasive tear film breakup time
meibomian expressibility and quality [an average of 1 year]
The expressibility and quality score of the meibum
TMH [an average of 1 year]
tear meniscus height

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Zhejiang University Hospital	Hangzhou		China

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: lin lin, Second Affiliated Hospital of Zhejiang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05070611

Other Study ID Numbers:

2021-0562

First Posted:

Oct 7, 2021

Last Update Posted:

Oct 7, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Chalazion

IPL

Meibomian gland function

Additional relevant MeSH terms:

Chalazion

Study Results

No Results Posted as of Oct 7, 2021