Effect of Nepafenac on Post-Operative Macular Swelling Following Uncomplicated Cataract Surgery - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 28, 2007

Last Updated Date

August 27, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

Retinal thickness as measured by optical coherence tomography [ Time Frame: 8 weeks ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00494494 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

ETDRS vision [ Time Frame: 8 weeks ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effect of Nepafenac on Post-Operative Macular Swelling Following Uncomplicated Cataract Surgery

Official Title ^†

Effect of Nepafenac on Post-Operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery

Brief Summary

Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery

Participants: Patients having cataract surgery at UNC who meet eligibility criteria

Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.

Detailed Description

We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month.

Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Cystoid Macular Edema

Intervention ^†

Drug: nepafenac

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

over age 50
having cataract surgery at UNC

Exclusion Criteria:

medically controlled diabetes
history of intraocualr surgery
abnormal pre-op optcal coherence tomography scan
history of ocular inflammation
have age related macular degeneration

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00494494

Responsible Party

Kenneth Cohen, MD, UNC Chapel Hill

Secondary IDs ^††

Study Sponsor ^†

University of North Carolina

Collaborators ^††

Research to Prevent Blindness

Investigators ^†

Principal Investigator:

Kenneth C Cohen, MD

The University of North Carolina, Chapel Hill

Information Provided By

The University of North Carolina, Chapel Hill

Verification Date

June 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.