Back to resultsEffect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Primary Purpose
Xerophthalmia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intense pulsed light therapy
Hot compress massage
Sponsored by
About this trial
This is an interventional treatment trial for Xerophthalmia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intense pulsed light therapy group
Hot compress massage group
Intense pulsed light therapy and hot compress massage group
Arm Description
Outcomes
Primary Outcome Measures
The length of meibomian glands after the treatment.
Length in millimeters.
The area of meibomian glands after the treatment.
Area in millimeters^2.
The percentage of meibomian glands after the treatment.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636372
Brief Title
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Official Title
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
An one-month follow-up was completed after the treatment.
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yune Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerophthalmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intense pulsed light therapy group
Arm Type
Experimental
Arm Title
Hot compress massage group
Arm Type
Experimental
Arm Title
Intense pulsed light therapy and hot compress massage group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intense pulsed light therapy
Intervention Description
Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.
Intervention Type
Other
Intervention Name(s)
Hot compress massage
Intervention Description
Patients with xerophthalmia were treated with hot compress massage of meibomian gland.
Primary Outcome Measure Information:
Title
The length of meibomian glands after the treatment.
Description
Length in millimeters.
Time Frame
up to 2 months
Title
The area of meibomian glands after the treatment.
Description
Area in millimeters^2.
Time Frame
up to 2 months
Title
The percentage of meibomian glands after the treatment.
Description
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.
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Meibomian Gland Related Therapy on the Morphology of Meibomian Gland
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