Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by TearScience, Inc.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT01808560
First received: March 7, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.


Condition Intervention
Blepharitis
Dry Eye Syndrome
Device: LipiFlow Pre-Treatment
Device: LipiFlow Post-treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for Treatment of Meibomian Gland Dysfunction (MGD) Prior to Cataract Surgery

Resource links provided by NLM:


Further study details as provided by TearScience, Inc.:

Primary Outcome Measures:
  • Mean change in total meibomian gland score [ Time Frame: 1 Month and 3 Months after surgery ] [ Designated as safety issue: No ]
    The primary endpoint assesses change in meibomian gland function by scoring the meibomian gland secretion characteristics before and after surgery. The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery.


Secondary Outcome Measures:
  • Mean change in Ocular Surface Disease Index (OSDI) questionnaire score [ Time Frame: 1 Month and 3 Months after surgery ] [ Designated as safety issue: No ]
    The secondary endpoint assesses the change in visual quality and ocular comfort before and after cataract surgery using the OSDI questionnaire. The secondary endpoint is the mean change in the OSDI questionnaire score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LipiFlow Pre-treatment
Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.
Device: LipiFlow Pre-Treatment
The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
Other Name: LipiFlow Thermal Pulsation System
No Intervention: Untreated Control
Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.
Experimental: LipiFlow Post-treatment
Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.
Device: LipiFlow Post-treatment
The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
Other Name: LipiFlow Thermal Pulsation System

Detailed Description:

This is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland dysfunction prior to planned bilateral cataract surgery. All subjects undergo examination to determine study eligibility and to capture the Baseline status prior to surgery. Subjects are randomized to receive LipiFlow treatment (Pre-treatment group) one month before cataract surgery or no LipiFlow treatment (Untreated Control group). Cataract surgery is performed on both eyes of each subject with the second eye surgery completed within two months of the first eye. All subjects are evaluated at one month and three months after cataract surgery on the second eye with comparison of the study endpoints between the Pre-treatment and Untreated groups. To facilitate subject recruitment, the Untreated Control group receives crossover LipiFlow treatment for MGD (Post-treatment group) three months after cataract surgery on the second eye.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55 to 85 years of age
  • Must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other MGD or dry eye treatments during the study; and attendance at all study visits
  • Meibomian gland dysfunction in both eyes based on total meibomian gland score
  • None to mild dry eye symptoms based on Ocular Surface Disease Index score
  • Tear film interferometry assessment of 100 units or less

Exclusion Criteria:

  • Systemic disease conditions that causes dry eye
  • Use of systemic medications known to cause dry eye
  • Use of other MGD or dry eye treatments except for over the counter lubricants or dietary supplements
  • History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
  • Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
  • Participation in another ophthalmic drug or device trial in the past month
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808560

Contacts
Contact: Christy Stevens, OD, MPH 919-467-4007 cstevens@tearscience.com

Locations
United States, Illinois
Chicago Cornea Consultants, Ltd. Recruiting
Hoffman Estates, Illinois, United States, 60169
Jackson Eye Recruiting
Lake Villa, Illinois, United States, 60046
United States, Massachusetts
Charles River Eye Associates Recruiting
Winchester, Massachusetts, United States, 01890
United States, Minnesota
Associated Eye Care Recruiting
Stillwater, Minnesota, United States, 55082
United States, Missouri
Ophthalmology Consultants, Ltd. Recruiting
St. Louis, Missouri, United States, 63131
United States, South Carolina
Carolina EyeCare Physicians, LLC Recruiting
Mt. Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
TearScience, Inc.
Investigators
Study Director: Christy Stevens, OD, MPH TearScience
  More Information

No publications provided

Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT01808560     History of Changes
Other Study ID Numbers: LF005
Study First Received: March 7, 2013
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eyelid Diseases
Blepharitis
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Cataract
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lens Diseases

ClinicalTrials.gov processed this record on September 14, 2014