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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05070611
Other study ID # 2021-0562
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date November 1, 2021

Study information

Verified date September 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact jin x ming
Phone 13989455778
Email 18344980413@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date November 1, 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 24 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

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

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 rate of the recurrent chalazia an average of 1 year
Secondary NITBUT non-invasive tear film breakup time an average of 1 year
Secondary meibomian expressibility and quality The expressibility and quality score of the meibum an average of 1 year
Secondary TMH tear meniscus height an average of 1 year
See also
  Status Clinical Trial Phase
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT02338648 - Safety and Efficacy Study of SUN 131 TDS as Compared to Placebo TDS in Adult Patients With a Chalazion Phase 2
Completed NCT00420628 - Pediatric Zylet Safety and Efficacy Study Phase 4
Withdrawn NCT01763437 - Intralesional Tetracycline Injection in the Treatment of Chalazia Phase 0
Completed NCT03248440 - Safety and Efficacy Study of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion Phase 3
Completed NCT00832130 - Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye N/A
Completed NCT04322500 - Probiotics for Chalaziosis Treatment in Children N/A
Completed NCT04342507 - Probiotics for Treatment of Chalazion in Adults N/A
Recruiting NCT02025023 - Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study Phase 3
Recruiting NCT05512572 - Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion N/A