Lipiflow Versus Warm Compresses in Parkinson's Disease

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Meibomian Gland Dysfunction

Treatments: Device: LipiFlow system; Procedure: Warm compresses

Study type: Interventional

Funder types: Other

Identifiers

NCT02894658

IRB00033387

Details and patient eligibility

About

The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction treatment.

Full description

Objectives To determine whether a single treatment with thermal pulsation relieves dry eye symptoms (primary objective) and improves objective findings of meibomian gland dysfunction in patients with Parkinsons disease.

Methods and Measures

Design

• Randomized, controlled trial
• Patient eyes will be randomized to either receive a single thermal pulsation treatment the FDA-approved Lipiflow thermal pulsation system or to use traditional eyelid hygiene or to use traditional eyelid hygiene

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction

Inclusion Criteria:

• Medical diagnosis of Parkinsons disease
• > 18 years-old
• Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit
• Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid)
• Willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study

Exclusion Criteria:

• Active intraocular inflammation
• Ocular surface abnormality that could potentially compromise corneal integrity in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Lipiflow system

Experimental group

Description:

Treatment through the use of heat and pulsatile pressure.

Treatment:

Device: LipiFlow system

Fellow eye warm compresses

Active Comparator group

Description:

Warm compresses to fellow eye and daily treatment with eyelid scrubs.

Treatment:

Procedure: Warm compresses