Lipiflow Versus Warm Compresses in Parkinson's Disease

NCT02894658 | Withdrawn FDA Device

• 1 other identifier: IRB00033387
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Tear break up time

  Four visits up to three months

• Assessment of dry eye symptoms with Ocular Surface Disease Index (OSDI) score before and after treatment

  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

  Four visits up to three months

• SPEED Questionnaire assessment of dry eye symptoms before and after treatment

  Four visits up to three months

Study Arms (2)

Lipiflow system

EXPERIMENTAL

Treatment through the use of heat and pulsatile pressure.

Device: LipiFlow system

Fellow eye warm compresses

ACTIVE COMPARATOR

Warm compresses to fellow eye and daily treatment with eyelid scrubs.

Procedure: Warm compresses

Interventions

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.

Lipiflow system

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.

Fellow eye warm compresses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active intraocular inflammation
• Ocular surface abnormality that could potentially compromise corneal integrity in either eye

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Susan Burden, MD

  Wake Forest Baptist Health Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 9, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share