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

Phase 4

• Conditions: Dry Eye
• Interventions: Device: Intense Pulse Light Energy delivery (IPL)

• Registration Number: NCT02992535
• Lead Sponsor: Carones Ophthalmology Center

Brief Summary

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

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 Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-10
• Study First Posted: 2016-12-14
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22
• Study Start: 2017-01
• Primary Completion: 2017-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Intense Pulse Light Energy delivery (IPL)	Intense pulse light therapy (E-Schwin)

Primary Outcome Measures

Name	Time	Method
Tear film osmolarity change	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).