Lipiflow Versus Warm Compresses in Parkinson's Disease
| Status: | Suspended |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/16/2018 |
| Start Date: | August 2016 |
| End Date: | January 2020 |
Prospective Fellow Eye Comparison of Traditional Meibomian Gland Disease Treatment Versus a Single Thermal Pulsation Treatment in Patients With Parkinsons Disease
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.
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
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
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
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