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Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity

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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
Sponsor:
Information provided by (Responsible Party):
Carones Ophthalmology Center

Brief Summary:
Evaluate changes in tear film osmolarity and other DED signs/symptoms following treatment with IPL.

Condition or disease Intervention/treatment Phase
Dry Eye Device: Intense Pulse Light Energy delivery (IPL) Phase 4

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Single arm
Intense pulse light therapy (E-Schwin)
Device: Intense Pulse Light Energy delivery (IPL)



Primary Outcome Measures :
  1. 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). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry eye
  • MGD

Exclusion Criteria:

  • No history of ocular infection or corneal degeneration/dystrophy
  • No history of corneal refractive surgery
  • No change in ocular medications in the last 2 months

Information from the National Library of Medicine

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


Contacts
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Contact: Francesco Carones, MD +390276318174 fcarones@carones.com

Sponsors and Collaborators
Carones Ophthalmology Center

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Responsible Party: Carones Ophthalmology Center
ClinicalTrials.gov Identifier: NCT02992535     History of Changes
Other Study ID Numbers: TLEUROPE1
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases