Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

NCT ID: NCT01808560

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

Blepharitis; Dry Eye Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

LipiFlow Pre-Treatment

Intervention Type: DEVICE

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.

Untreated Control

Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

LipiFlow Post-treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

LipiFlow Thermal Pulsation System; LipiFlow Thermal Pulsation System

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TearScience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christy Stevens, OD, MPH

Role: STUDY_DIRECTOR

TearScience

Locations

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, United States

Jackson Eye

Lake Villa, Illinois, United States

Charles River Eye Associates

Winchester, Massachusetts, United States

Associated Eye Care

Stillwater, Minnesota, United States

Ophthalmology Consultants, Ltd.

St Louis, Missouri, United States

The May Eye Care Center

Hanover, Pennsylvania, United States

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Countries

United States

Other Identifiers

LF005

Identifier Type: -

Identifier Source: org_study_id