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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystoid Macular Edema
• Intervention / Treatment: Drug: Standard Care; Drug: nepafenac

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• over age 50
• having cataract surgery at UNC

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Treatment; topical antibiotic for 10 days and a topical corticosteroid for 1 month	Drug: Standard Care; topical antibiotic for 10 days plus topical corticosteroids for 1 month
Experimental: Nepafenac; 1 drop per study eye three times per day for 30 days in addition to standard care	Drug: nepafenac; liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)	The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)	baseline and 8 weeks
Pre-operative Best Corrected Visual Acuity (BCVA)	Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.	baseline
Foveal Thickness	difference in mean pre-post changes by the two treatment groups	baseline and 8 weeks
Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)		baseline and 8 weeks
Post-operative Best Corrected Visual Acuity (BCVA)	The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Research to Prevent Blindness
• Investigators: Principal Investigator: Kenneth C Cohen, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: June 28, 2007
• First Submitted That Met QC Criteria: June 28, 2007
• First Posted (Estimate): June 29, 2007

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: optical coherence tomography; cataract; cystoid macular edema; nonsteroidal antiinflammatory drugs
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Lens Diseases; Macular Edema; Cataract; Edema; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nepafenac
• Other Study ID Numbers: 05-3115