Meibomian Gland Dysfunction
Conditions
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
Interventions
DEVICELipiFlow system
LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.
PROCEDUREWarm 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed