NCT05512572

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

August 21, 2022

Last Update Submit

September 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of chalazia

    The recurrence of the chalazia

    An average of 1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

Receiving IPL-MGD treatment.

Device: IPL

Control group

ACTIVE COMPARATOR

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).

Procedure: Conservative treatment or excision with curettage

Interventions

IPLDEVICE

intense pulsed light

Experimental group

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients had primary or recurrent eyelid plate gland cyst without obvious surgical indications

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Chalazion

Interventions

Conservative TreatmentCurettage

Condition Hierarchy (Ancestors)

CystsNeoplasmsEyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2022

First Posted

August 23, 2022

Study Start

August 23, 2021

Primary Completion

October 30, 2021

Study Completion

August 23, 2023

Last Updated

September 21, 2022

Record last verified: 2021-09

Locations