Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Bp Consulting

Status and phase

Completed

Phase 4

Conditions

Cataracts

Treatments

Drug: Xibrom, and Optive

Drug: Xibrom and Pred Forte

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00698724

5359

Details and patient eligibility

About

To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female at least 18 years of age.
- Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
- Patients should be in good general health and devoid of recognized risk factors for CME.
- Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
- Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
- Only one eye of each treated patient may be included in the study

Exclusion criteria

Any known contraindications to any study medication or their component
Presence of uncontrolled systemic disease
Required use of other ocular medications during the study

o Artificial tears may be used
Diabetics with any clinically evident or history of retinopathy
Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
Abnormal pre-operative OCT (if obtainable)