Treatment of Meibomian Gland Dysfunction Prior to 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