Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
lack of equipment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipiflow system | Experimental | Treatment through the use of heat and pulsatile pressure. |
|
| Fellow eye warm compresses | Active Comparator | Warm compresses to fellow eye and daily treatment with eyelid scrubs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipiFlow system | Device | LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Four visits up to three months |
| Measure | Description | Time Frame |
|---|---|---|
| Tear break up time | Tear break up time defined measured with the fluorescein tear break up time (FBUT) method and categorized as follows
| Four visits up to three months |
Not provided
Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Burden, MD | Wake Forest Baptist Health Eye Center | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Warm compresses | Procedure | 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. |
|
| 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. |
| 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 | Four visits up to three months |
| Corneal Staining | • Corneal staining
| 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. | Four visits up to three months |