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

Completed · Phase 4

Conditions studied: Cataracts

In brief

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.

Key facts

Study ID

NCT00698724

Run by

Bp Consulting, Inc

People needed

200

Starts

2008-06-01

Expected to finish

2009-06-01

Last updated by the study team

2009-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• St. Luke's Cataract and Laser institute — Tarpon Springs, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.