Lipiflow Versus Warm Compresses in Parkinson's Disease

Not Applicable

Withdrawn

• Conditions: Meibomian Gland Dysfunction
• Interventions: Procedure: Warm compresses; Device: LipiFlow system

• Registration Number: NCT02894658
• Lead Sponsor: Wake Forest University Health Sciences

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

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-03
• Study First Posted: 2016-09-09
• Status Verified: 2022-12
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fellow eye warm compresses	Warm compresses	Warm compresses to fellow eye and daily treatment with eyelid scrubs.
Lipiflow system	LipiFlow system	Treatment through the use of heat and pulsatile pressure.

Primary Outcome Measures

Name	Time	Method
Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.	Four visits up to three months	Expressed secretion characteristics graded on a scale: 3 (clear liquid secretion); 2 (cloudy liquid secretion); 1 (inspissated/toothpaste consistency); 0 (no secretion); Meibomian gland metrics will be calculated: A) Total meibomian gland score (sum of the grades for all 15 glands with a range from 0 to 45); B) The number of glands secreting any liquid (clear or cloudy liquid with a grade of 2 or 3) of the 15 glands assessed; C) The number of glands yielding the optimal clear liquid secretion (clear liquid with a grade of 3) of the 15 glands assessed.

Secondary Outcome Measures

Name	Time	Method
Tear break up time	Four visits up to three months	Tear break up time defined measured with the fluorescein tear break up time (FBUT) method and categorized as follows; * "Dry" defined as FBUT values of 1-5 seconds; * "Marginal" defined as FBUT of 6-9 seconds; * "Normal" defined as FBUT of 10 or greater seconds
Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment	Four visits up to three months	The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.
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	Four visits up to three months
Corneal Staining	Four visits up to three months	• Corneal staining; * Evaluated with a slit-lamp biomicroscope 90 seconds after instillation of fluorescein dye using a standard strip method; * Corneal staining is based on the Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye and will be graded on a scale of 0 (none) - 3 (severe) with a total corneal staining grade range from 0 to 15
SPEED Questionnaire assessment of dry eye symptoms before and after treatment	Four visits up to three months	SPEED Questionnaire rating of types, frequency, and severity of symptoms. Frequency is grade 0 to 3. Severity is grade 0 to 4. Higher grades represent greater disability.