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OpenTrials
Completed

NCT Number: NCT00758199

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Altos Eye Physicians

Los Altos, California, 94024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female >18 years of age scheduled to undergo bilateral 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 > [greater than or equal to] 20/30 postoperatively
  • 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
  • Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
  • 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

Treatment and study plan

bromfenac

Drug

Group 1: Bromfenac BID for 3 weeks Group 2: Bromfenac BID for 6 weeks

Other names: Bromfenac (Xibrom)

Moxifloxacin Hydrochloride

Drug

Group 1 and Group 2:Moxifloxacin hydrochloride 1 day prior to surgery-continue for six days after surgery.

Other names: Moxifloxacin hydrochloride (Vigamox)

Prednisolone Acetate

Drug

Group 1 and Group 2:Prednisolone Acetate for 3 weeks in a tapering schedule (week 1: TID; week 2: BID, week 3:QD).

Other names: Omni-Pred

Primary outcomes

  1. OCT with macular thickening

    Time frame: 3-6 weeks

Secondary outcomes

  1. Incidence of CME

    Time frame: 3-6 weeks

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 25, 2008
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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