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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.
Warm compresses will be applied to fellow eye and that eye will undergo daily treatment with eyelid scrubs using a warm wash cloth and "no tears" baby shampoo every morning and warm compresses on the eyelids for 5-10 minutes twice a day. Patients will be instructed on how to perform proper lid hygiene at the initial visit.
Meibomian gland assessment defined as assessment of 15 glands on the lower eyelid margin using a handheld instrument, the Meibomian Gland Evaluator.
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.
Time frame: Four visits up to three months
Tear break up time
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
Time frame: Four visits up to three months
Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment
The OSDI score is assessed on a scale of 0 to 100 with higher scores representing greater disability.
Time frame: Four visits up to three months
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
Time frame: Four visits up to three months
Corneal Staining
• 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
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Time frame: Four visits up to three months
SPEED Questionnaire assessment of dry eye symptoms before and after treatment
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.
Time frame: Four visits up to three months