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
NCT ID: NCT00698724
Last Updated: 2009-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2008-06-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Group 1: Xibrom, Optive
Xibrom, and Optive
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
2
Group 2: Xibrom, Pred Forte
Xibrom and Pred Forte
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.
Interventions
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Xibrom, and Optive
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
Xibrom and Pred Forte
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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Bp Consulting, Inc
NETWORK
Responsible Party
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St. Luke's Cataract and Laser Institute
Principal Investigators
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James Gills, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Cataract and Laser Institute
Locations
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St. Luke's Cataract and Laser institute
Tarpon Springs, Florida, United States
Countries
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Other Identifiers
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5359
Identifier Type: -
Identifier Source: org_study_id
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