Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Inclusion Criteria:

• Male or female at least 18 years of age.

  • Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
  • Patients should be in good general health and devoid of recognized risk factors for CME.
  • Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
  • Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
  • Only one eye of each treated patient may be included in the study

Exclusion Criteria:

• Any known contraindications to any study medication or their component

• Presence of uncontrolled systemic disease

• Required use of other ocular medications during the study

  o Artificial tears may be used

• Diabetics with any clinically evident or history of retinopathy

• Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation

• Abnormal pre-operative OCT (if obtainable)