Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion

Chalazion Clinical Trial

Official title:

Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512572
• Other study ID #: 2021-0563
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 23, 2023

Study information

• Verified date: September 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: ming xiu jin
• Phone: 13989455778
• Email: mailto:18344980413[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 23, 2023
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chalazion

Intervention

Device:
• IPL
intense pulsed light

Procedure:
• Conservative treatment or excision with curettage
conservative treatment or excision with curettage but without IPL-MGX treatment as a control

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of chalazia	The recurrence of the chalazia	An average of 1 year