Status:
UNKNOWN
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
Lead Sponsor:
Innovative Medical
Conditions:
Pseudophakia
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.
Detailed Description
Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, th...
Eligibility Criteria
Inclusion
- Male or female \>18 years of age scheduled to undergo cataract surgery
- Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- Expected visual outcome of BCVA (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography).
- Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Exclusion
- Known contraindication to any study medication or any of their components
- Required use of ocular medications other than the study medications during the study
- Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography)
- Presence of significant dry macular degeneration that may impact postoperative visual results.
- History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation.
- Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- Anticipated need for mechanical iris dilating devices
- Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01193504
Start Date
September 1 2010
End Date
October 1 2012
Last Update
June 14 2012
Active Locations (3)
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1
Harvard Eye Associates
Laguna Hills, California, United States, 92653
2
The Center For Excellence in Eye care
Miami, Florida, United States, 33176
3
Ophthalmic Consultants of Boston
Waltham, Massachusetts, United States, 02451