Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Not Applicable

Completed

Interventions: Device: LipiFlow Pre-Treatment
Device: LipiFlow Post-treatment

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
LipiFlow Pre-treatment	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.
LipiFlow Post-treatment	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Total Meibomian Gland Score	Baseline and 3 Months post-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. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range of 0 to 45.

Secondary Outcome Measures

Name	Time	Method
Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months	Baseline and 3 Months post-surgery	Assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 0 (no problems), 1 (tolerable-not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is calculated as sum of frequency and severity scores for symptoms over a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.

Locations (7): Jackson Eye
🇺🇸
Lake Villa, Illinois, United States
Chicago Cornea Consultants, Ltd.
🇺🇸
Hoffman Estates, Illinois, United States
Charles River Eye Associates
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Winchester, Massachusetts, United States
Ophthalmology Consultants, Ltd.
🇺🇸
Saint Louis, Missouri, United States
Associated Eye Care
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Stillwater, Minnesota, United States
The May Eye Care Center
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Hanover, Pennsylvania, United States
Carolina EyeCare Physicians, LLC
🇺🇸
Mount Pleasant, South Carolina, United States