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

Carones Ophthalmology Center

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Device: Intense Pulse Light Energy delivery (IPL)

Study type: Interventional

Funder types: Other

Identifiers

NCT02992535

TLEUROPE1

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Single arm

Experimental group

Description:

Intense pulse light therapy (E-Schwin)

Treatment:

Device: Intense Pulse Light Energy delivery (IPL)