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

December 21, 2016 updated by: Carones Ophthalmology Center

Effect of Intense Pulse Light (IPL) Treatment on Tear Film Osmolarity in Dry Eye Disease (DED) With Meibomian Gland Dysfunction (MGD).

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single arm
Intense pulse light therapy (E-Schwin)
Device: Intense Pulse Light Energy delivery (IPL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carones Ophthalmology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (ESTIMATE)

December 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLEUROPE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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