Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

Dry Eye Syndrome Clinical Trial

Official title:

Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958514
• Other study ID #: 2016154
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the efficacy of intense pulsed light in treating dry eye caused by meibomian gland dysfunction and make a comparison between the traditional treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 78 Years

Eligibility

Inclusion Criteria:

• patients with dry eye syndrome and diagnosed as MGD

Exclusion Criteria:

• an infection or inflammatory disease;

• ocular surgical history with in the last 3 months

• SGOGREN SYNDROME

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Device:
• intense pulsed light
Intense pulse light (IPL) has been used in dermatology practices for several years as a treatment for rosacea and acne.IPL uses Xenon flashlamp to emit wavelengths of light from 400 to 1200nm. When placed on the light, a filter restricts the wavelength to the visible light range of *500nm.In 2007-2008, an IPL treatment technology-the Diamond Q4 by DermaMed Solutions-was specifically configured to our specifications with the goal of stimulating secretion of normal meibum via skin treatment effects on the meibomian glands. It was discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands.

Drug:
• Tobramycin and Dexamethasone Ophthalmic Ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index (OSDI)	normal value:<13 abnormal value:= 13	through study completion,an average of 6 months
Secondary	The concentrations of inflammatory cytokines such as IL-1?IL-6 and IL-8		through study completion,an average of 6 months
Secondary	breakup time of tear film (BUT)	normal value:>10s abnormal value:= 10s	through study completion,an average of 6 months
Secondary	Corneal Fluorescein Stain(CFS)		through study completion,an average of 6 months
Secondary	Eyelid ester discharge ability score		through study completion,an average of 6 months
Secondary	Eyelid ester trait ratings		through study completion,an average of 6 months