A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

Inclusion Criteria (all criteria apply to each study eye):

- Minimum 22 years of age.

- Bilateral cataracts for which phacoemulsification extraction and implantation with
Symfony IOLs have been planned.

- Evidence of Meibomian Gland Dysfunction (MGD) in both eyes based on assessment of
meibomian glands of the lower eyelid

- None to moderate dry eye symptoms with questionnaire

- Clear intraocular media other than cataract in each eye.

- Availability, willingness, ability and sufficient cognitive awareness to comply with
the study protocol including: randomization; examination procedures; completion of
planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye
treatments.

- Ability to understand, read and write English to consent to study participation and
complete study questionnaires.

- Willingness to sign informed consent and HIPAA authorization or equivalent
documentation necessary to comply with applicable privacy laws pertaining to medical
treatment in the governing country.

Exclusion Criteria (all criteria apply to each study eye):

- Any medical finding that would predictably result in a postoperative best corrected
distance visual acuity worse than 20/30 in either eye.

- Use of systemic or ocular medications that, in the opinion of the investigator, may
affect vision or impact pupil dilation or iris structure.

- Irregular corneal astigmatism.

- Any clinically-significant corneal pathology / abnormality other than regular corneal
astigmatism.

- Any clinically-significant pupil abnormalities.

- Subjects with conditions associated with increased risk of zonular rupture.

- Unwillingness or inability to stop wearing contact lens at least two weeks prior to
the baseline visit.

- Known ocular disease or pathology that, in the opinion of the investigator, may affect
visual acuity or require surgical intervention during the study.

- Systemic disease condition that causes dry eye.

- Unwillingness or inability to abstain from the use of systemic medications known to
cause dryness for the study duration. Subjects must have discontinued these
medications for at least 1 month prior to Preoperative Visit.

- Unwillingness or inability to abstain from the use of systemic antihistamines.

- Unwillingness or inability to abstain from use of prescription medications for
treatment of MGD or dry eye. Subject must have dicontinued using prescription
medications for MGD or dry eye at least 1 month prior to baseline preoperative visit
#1 measurements.

- Any of the following ocular (eye or eyelid) conditions in either eye within 3 months
prior to the LipiFlow treatment visit:

- Prior intraocular, oculoplastic, corneal or refractive surgery procedure (LASIK,
LASEK, RK, PRK, etc.).

- Ocular trauma.

- Ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.

- History of recurrent ocular inflammation.

- Punctal plug insertion or punctal occlusion.

- Any of the following active ocular (eye or eyelid) conditions in either eye at the
baseline Preoperative Visit #1 measurements:

- Ocular infection.

- Ocular inflammation.

- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis

- Severe (Grade 3 or 4) inflammation of the eyelid.

- Eyelid abnormalities that affect lid function.

- Ocular surface abnormality that may compromise corneal integrity.

- Concurrent participation or participation within 30 days prior to study visit in any
other clinical trial.

- Planned monovision correction.

- Patient is pregnant, plans to become pregnant, is lactating or has another condition
associated with the fluctuation of hormones that could lead to refractive changes.