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Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland

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ClinicalTrials.gov Identifier: NCT04636372
Recruitment Status : Withdrawn (An one-month follow-up was completed after the treatment.)
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Yune Zhao, Wenzhou Medical University

Brief Summary:
200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.

Condition or disease Intervention/treatment Phase
Xerophthalmia Device: Intense pulsed light therapy Other: Hot compress massage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Intense pulsed light therapy group Device: Intense pulsed light therapy
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.

Experimental: Hot compress massage group Other: Hot compress massage
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.

Experimental: Intense pulsed light therapy and hot compress massage group Device: Intense pulsed light therapy
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.

Other: Hot compress massage
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.




Primary Outcome Measures :
  1. The length of meibomian glands after the treatment. [ Time Frame: up to 2 months ]
    Length in millimeters.

  2. The area of meibomian glands after the treatment. [ Time Frame: up to 2 months ]
    Area in millimeters^2.

  3. The percentage of meibomian glands after the treatment. [ Time Frame: up to 2 months ]
    Percentage of meibomian glands in %(area of meibomian glands (mm^2) and area of palpebral conjunctiva (mm^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated patients with xerophthalmia

Exclusion Criteria:

  • No history of ocular surgery and trauma
  • Any eye diseases except xerophthalmia
  • No treated for xerophthalmia before
  • Successful completion of follow-ups
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Responsible Party: Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04636372    
Other Study ID Numbers: LXY-meibomian gland
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Xerophthalmia
Conjunctival Diseases
Eye Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases