Lipiflow Versus Warm Compresses in Parkinson's Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
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Randomized, controlled trial
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lipiflow system Treatment through the use of heat and pulsatile pressure. |
Device: LipiFlow system
LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.
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| Active Comparator: Fellow eye warm compresses Warm compresses to fellow eye and daily treatment with eyelid scrubs. |
Procedure: Warm compresses
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction
Inclusion Criteria:
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Medical diagnosis of Parkinsons disease
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18 years-old
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Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit
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Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid)
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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:
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Active intraocular inflammation
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Ocular surface abnormality that could potentially compromise corneal integrity in either eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest Baptist Health Eye Center | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Susan Burden, MD, Wake Forest Baptist Health Eye Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00033387