Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02992535|
Recruitment Status : Unknown
Verified December 2016 by Carones Ophthalmology Center.
Recruitment status was: Not yet recruiting
First Posted : December 14, 2016
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Device: Intense Pulse Light Energy delivery (IPL)||Phase 4|
Prospective study design among subjects with MGD and qualifying for IPL therapy.
Study testing done at baseline visit when subjects are scheduled for IPL therapy. Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4).
Subjects willing to come for follow up visits as scheduled and may not have instilled any artificial tears 2 hours prior to study measurements.
No history of ocular infection or corneal degeneration/dystrophy No history of corneal refractive surgery and/or change in ocular medications in the last 2 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Single arm
Intense pulse light therapy (E-Schwin)
Device: Intense Pulse Light Energy delivery (IPL)
- Tear film osmolarity change [ Time Frame: Measurements will be made on day 15 (prior to second IPL sitting), Day 45 (prior to third IPL setting), Day 75 (fourth IPL setting) and Day 105 as needed (30 days after IPL setting 4). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992535
|Contact: Francesco Carones, MDfirstname.lastname@example.org|