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Effect of Nepafenac on Post-Operative Macular Swelling Following Uncomplicated Cataract Surgery
This study has been completed.
First Received: June 28, 2007   Last Updated: August 27, 2008   History of Changes
Sponsors and Collaborators: University of North Carolina
Research to Prevent Blindness
Information provided by: The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00494494
  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: nepafenac
Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Cataract Edema Surgery
Drug Information available for: Nepafenac
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Effect of Nepafenac on Post-Operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery

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

Primary Outcome Measures:
  • Retinal thickness as measured by optical coherence tomography [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • ETDRS vision [ Time Frame: 8 weeks ]

Estimated Enrollment: 80
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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 intraocualr surgery
  • abnormal pre-op optcal coherence tomography scan
  • history of ocular inflammation
  • have age related macular degeneration
  Contacts and Locations
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
Research to Prevent Blindness
Investigators
Principal Investigator: Kenneth C Cohen, MD The University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: UNC Chapel Hill ( Kenneth Cohen, MD )
Study ID Numbers: 05-3115
Study First Received: June 28, 2007
Last Updated: August 27, 2008
ClinicalTrials.gov Identifier: NCT00494494     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Eye Diseases
Edema
Macular Degeneration
Retinal Degeneration
Lens Diseases
Macular Edema
Signs and Symptoms
Analgesics, Non-Narcotic
Cataract
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Retinal Diseases

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

ClinicalTrials.gov processed this record on May 06, 2009