Clinical trial NCT01193504: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pseudophakia
Cataract Surgery
Keywords: Prevention of Retinal Thickening and CME Following Phacoemulsification
Pseudophakia following cataract surgery
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Prevention Of Retinal Thickening
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Miami
country: United States
facility: The Center For Excellence in Eye care
state: Florida
city: Waltham
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: The Center for Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Eye Associates
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalmic Consultants of Boston
name: Bonnie Henderson, MD
role: PRINCIPAL_INVESTIGATOR
References: