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
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cystoid Macular Edema
Interventions: Drug: Standard Care
Drug: nepafenac

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Treatment These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
Nepafenac 1 drop per study eye three times per day for 30 days plus standard care

Participant Flow:   Overall Study
    Standard Treatment     Nepafenac  
STARTED     40     39  
COMPLETED     40     39  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Treatment These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
Nepafenac 1 drop per study eye three times per day for 30 days plus standard care
Total Total of all reporting groups

Baseline Measures
    Standard Treatment     Nepafenac     Total  
Number of Participants  
[units: participants]
  40     39     79  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     40     39     79  
Age  
[units: years]
Mean ± Standard Deviation
  70.33  ± 8.04     73.95  ± 8.99     72.14  ± 8.52  
Gender  
[units: participants]
     
Female     19     18     37  
Male     21     21     42  
Region of Enrollment  
[units: participants]
     
United States     40     39     79  



  Outcome Measures
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1.  Primary:   Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)   [ Time Frame: baseline and 8 weeks ]

2.  Primary:   Pre-operative Best Corrected Visual Acuity (BCVA)   [ Time Frame: baseline ]

3.  Primary:   Foveal Thickness   [ Time Frame: baseline and 8 weeks ]

4.  Primary:   Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)   [ Time Frame: baseline and 8 weeks ]

5.  Primary:   Post-operative Best Corrected Visual Acuity (BCVA)   [ Time Frame: baseline and 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Although the peak incidence of CME is said to be at 4–12 weeks after surgery, we may have missed the time course for detecting the maximum increased OCT measured macular thickness.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kennth L. Cohen, MD
Organization: University of North Carolina at Chapel Hill
phone: 919 843-0292
e-mail: klc@med.unc.edu


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