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

This study has been completed.
Sponsor:
Collaborator:
Research to Prevent Blindness
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00494494
First received: June 28, 2007
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Cystoid Macular Edema
Drug: Standard Care
Drug: nepafenac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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)

  • Pre-operative Best Corrected Visual Acuity (BCVA) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Foveal Thickness [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    difference in mean pre-post changes by the two treatment groups

  • Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Post-operative Best Corrected Visual Acuity (BCVA) [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 82
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494494

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

No publications provided

Responsible Party: Kenneth Cohen, MD, UNC Chapel Hill
ClinicalTrials.gov Identifier: NCT00494494     History of Changes
Other Study ID Numbers: 05-3115
Study First Received: June 28, 2007
Results First Received: April 11, 2011
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
cystoid macular edema
cataract
nonsteroidal antiinflammatory drugs
optical coherence tomography

Additional relevant MeSH terms:
Cataract
Edema
Macular Edema
Eye Diseases
Lens Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Nepafenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014