Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion

NCT ID: NCT05512572

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2023-08-23

Brief Summary

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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.

Detailed Description

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Conditions

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Chalazion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Receiving IPL-MGD treatment.

Group Type EXPERIMENTAL

IPL

Intervention Type DEVICE

intense pulsed light

Control group

Another set of age, sex and diagnosis matched consecutive cases of chalazion, who received conservative treatment or excision with curettage but without IPL-MGX treatment as a control (Non-IPL group).

Group Type ACTIVE_COMPARATOR

Conservative treatment or excision with curettage

Intervention Type PROCEDURE

conservative treatment or excision with curettage but without IPL-MGX treatment as a control

Interventions

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IPL

intense pulsed light

Intervention Type DEVICE

Conservative treatment or excision with curettage

conservative treatment or excision with curettage but without IPL-MGX treatment as a control

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital of Zhejiang University Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ming xiu jin

Role: CONTACT

rui yi zhu

Role: CONTACT

Facility Contacts

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rui 6yi zhu

Role: primary

Other Identifiers

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2021-0563

Identifier Type: -

Identifier Source: org_study_id

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