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

NCT02958514 | Completed

• 1 other identifier: 2016154
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dry Eye Syndrome

Keywords

IPL; MGD

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  normal value：\<13 abnormal value：≥ 13

  through study completion,an average of 6 months

Secondary Outcomes (5)

• The concentrations of inflammatory cytokines such as IL-1、IL-6 and IL-8

  through study completion,an average of 6 months

• breakup time of tear film （BUT）

  through study completion,an average of 6 months

• Corneal Fluorescein Stain(CFS)

  through study completion,an average of 6 months

• Eyelid ester discharge ability score

  through study completion,an average of 6 months

• Eyelid ester trait ratings

  through study completion,an average of 6 months

Study Arms (2)

traditional treatment group

OTHER

Subjects in this group are treated by tobramycin and dexamethasone ophthalmic ointment qn and artificial tears qid.

Drug: Tobramycin and Dexamethasone Ophthalmic Ointment

IPL treatment group

EXPERIMENTAL

Subjects in this group are treated with 3 cycles of intense pulsed light of 4 weeks interval and artificial tears qid.

Device: intense pulsed light

Interventions

intense pulsed light DEVICE

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.

IPL treatment group

Tobramycin and Dexamethasone Ophthalmic Ointment DRUG

traditional treatment group

Eligibility Criteria

• Age: 26 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with dry eye syndrome and diagnosed as MGD

You may not qualify if:

• an infection or inflammatory disease;
• ocular surgical history with in the last 3 months
• SGOGREN SYNDROME

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Intense Pulsed Light Therapy; Tobramycin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.PHD.

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share