Status:
COMPLETED
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
Lead Sponsor:
Bp Consulting, Inc
Conditions:
Cataracts
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 me...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00698724
Start Date
June 1 2008
End Date
June 1 2009
Last Update
June 10 2009
Active Locations (1)
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1
St. Luke's Cataract and Laser institute
Tarpon Springs, Florida, United States, 34688