Intense Pulse Light Treatment With Meibomian Gland Expression of the Upper Eyelids in Dry Eye Disease
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ClinicalTrials.gov Identifier: NCT03658811 |
Recruitment Status :
Completed
First Posted : September 5, 2018
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Dry Eye |
Intervention |
Device: intense pulsed light |
Enrollment | 19 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Upper Eyelid Meibomian Gland Dysfunction |
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Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose |
Period Title: Overall Study | |
Started | 19 |
Completed | 16 |
Not Completed | 3 |
Reason Not Completed | |
Lost to Follow-up | 3 |
Arm/Group Title | Upper Eyelid Meibomian Gland Dysfunction | |
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Patients with symptoms of dry eye disease in spite of previous or current use of currently available over the counter or prescription medications for dry eye and evidence of upper eyelid meibomian gland dysfunction and no prior intense pulsed light treatments or meibomian gland expression treatments intense pulsed light: Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose |
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Overall Number of Baseline Participants | 19 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
13 68.4%
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>=65 years |
6 31.6%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 19 participants | |
64.05
(49 to 86)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
Female |
15 78.9%
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Male |
4 21.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 19 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
19 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 19 participants |
19 |
Name/Title: | Dillon O'Brien |
Organization: | Toyos Clinic |
Phone: | 6153274015 ext 6 |
EMail: | dobrien@toyosclinic.com |
Responsible Party: | Toyos Clinic |
ClinicalTrials.gov Identifier: | NCT03658811 |
Other Study ID Numbers: |
TCLum-001 |
First Submitted: | August 29, 2018 |
First Posted: | September 5, 2018 |
Results First Submitted: | December 6, 2018 |
Results First Posted: | February 12, 2019 |
Last Update Posted: | February 12, 2019 |