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Completed

NCT Number: NCT02958514

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

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

26 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Tobramycin and Dexamethasone Ophthalmic Ointment

Drug

Primary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: through study completion,an average of 6 months

    normal value：<13 abnormal value：≥ 13

Secondary outcomes

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

    Time frame: through study completion,an average of 6 months

  2. breakup time of tear film （BUT）

    Time frame: through study completion,an average of 6 months

    normal value：>10s abnormal value：≤ 10s

  3. Corneal Fluorescein Stain(CFS)

    Time frame: through study completion,an average of 6 months

  4. Eyelid ester discharge ability score

    Time frame: through study completion,an average of 6 months

  5. Eyelid ester trait ratings

    Time frame: through study completion,an average of 6 months

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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