Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

Center For Excellence In Eye Care

Status and phase: Completed; Phase 4

Conditions: Retinal Thickening; Cystoid Macular Edema,

Treatments: Drug: 2. Xibrom (Bromfenac); Drug: 1. Pred Forte

Study type: Interventional

Funder types: Other

Identifiers

NCT00469781

5306

Details and patient eligibility

About

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• · Male or female > 18 years of age scheduled to undergo cataract surgery

  • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  • Expected visual outcome of 20/25 or better.
  • Ability to provide informed consent and likely to complete all study visits

Exclusion criteria

• · Known contraindication to any study medication or any of their components

  • Uncontrolled systemic disease
  • Required use of ocular medications other than the study medications during the study
  • Abnormal pre-operative OCTs
  • Diabetic patients with a history of macular edema or diabetic retinopathy
  • AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
  • Only one eye of each patient can be enrolled

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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95 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: 1. Pred Forte

2

Other group

Treatment:

Drug: 2. Xibrom (Bromfenac)