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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:September 2010
End Date:October 2012
Contact:Jenna Piel
Email:j.piel@imedsonline.com
Phone:(951)653-5566

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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.

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, these findings would demonstrate that physicians have other treatment
options to consider.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
3
sites
Waltham, Massachusetts 02451
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Waltham, MA
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Laguna Hills, California 92653
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Laguna Hills, CA
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Miami, Florida 33176
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Miami, FL
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