Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery

Pilot Study for Treatment of Meibomian Gland Dysfunction (MGD) Prior to Cataract Surgery

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.

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.

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