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

• ClinicalTrials.gov Identifier: NCT00494494
• Recruitment Status: Completed
• First Posted: June 29, 2007
• Results First Posted: July 12, 2011
• Last Update Posted: July 12, 2011
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Research to Prevent Blindness
• Information provided by: University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cystoid Macular Edema	Drug: Standard Care; Drug: nepafenac	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery
• Study Start Date: June 2007
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) [ Time Frame: baseline and 8 weeks ]
   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)
2. Pre-operative Best Corrected Visual Acuity (BCVA) [ Time Frame: baseline ]
   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.
3. Foveal Thickness [ Time Frame: baseline and 8 weeks ]
   difference in mean pre-post changes by the two treatment groups
4. Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) [ Time Frame: baseline and 8 weeks ]
5. Post-operative Best Corrected Visual Acuity (BCVA) [ Time Frame: baseline and 8 weeks ]
   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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27517

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Research to Prevent Blindness

Investigators

• Principal Investigator: Kenneth C Cohen, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: Kenneth Cohen, MD, UNC Chapel Hill
• ClinicalTrials.gov Identifier: NCT00494494
• Other Study ID Numbers: 05-3115
• First Posted: June 29, 2007
• Results First Posted: July 12, 2011
• Last Update Posted: July 12, 2011
• Last Verified: June 2011

Keywords provided by University of North Carolina, Chapel Hill:

cystoid macular edema; cataract; nonsteroidal antiinflammatory drugs; optical coherence tomography

Additional relevant MeSH terms:

Cataract; Macular Edema; Edema; Lens Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Nepafenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents