Clinical trial NCT02894658: Lipiflow Versus Warm Compresses in Parkinson's Disease
Official title: Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.
timeFrame: Four visits up to three months
Secondary outcomes:
measure: Tear break up time
timeFrame: Four visits up to three months
measure: Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment
timeFrame: Four visits up to three months
measure: Best spectacle-corrected visual acuity (BSCVA) with high-contrast Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart using the ETDRS-Fast method under standard illumination
timeFrame: Four visits up to three months
measure: Corneal Staining
timeFrame: Four visits up to three months
measure: SPEED Questionnaire assessment of dry eye symptoms before and after treatment
timeFrame: Four visits up to three months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest Baptist Health Eye Center
name: Susan Burden, MD
role: PRINCIPAL_INVESTIGATOR
References: