Loading clinical trials...

UNKNOWNPHASE4

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

NCT01193504•Innovative Medical

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

Harvard Eye Associates

Laguna Hills, California, United States

The Center For Excellence in Eye care

Miami, Florida, United States

Ophthalmic Consultants of Boston

Waltham, Massachusetts, United States

Key Dates

Start Date

September 1, 2010

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

June 14, 2012

Enrollment

100

ESTIMATED participants

Conditions

PseudophakiaCataract Surgery

Interventions

Pred Forte

DRUG

Lotemax

DRUG

Contacts

Jenna Piel

CONTACT

(951)653-5566 j.piel@imedsonline.com

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

View study

RECRUITINGNA

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

NCT07178639

Macular OedemaCataract Surgery+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

Oral vs IV Sedation for Cataract Surgery in Older Adults

Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options

Reliability and Effectiveness of New Enova Preloaded Intaocular Lens and Cartridge System

Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule