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Trial record 19 of 25 for:    "Lens Disease" | "Nepafenac"

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

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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:
Collaborator:
Research to Prevent Blindness
Information provided by:
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cystoid Macular Edema
Interventions Drug: Standard Care
Drug: nepafenac
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. 1 drop per study eye three times per day for 30 days plus standard care
Period Title: Overall Study
Started 40 39
Completed 40 39
Not Completed 0 0
Arm/Group Title Standard Treatment Nepafenac Total
Hide Arm/Group Description These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. 1 drop per study eye three times per day for 30 days plus standard care Total of all reporting groups
Overall Number of Baseline Participants 40 39 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
40
 100.0%
39
 100.0%
79
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 39 participants 79 participants
70.33  (8.04) 73.95  (8.99) 72.14  (8.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 39 participants 79 participants
Female
19
  47.5%
18
  46.2%
37
  46.8%
Male
21
  52.5%
21
  53.8%
42
  53.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 39 participants 79 participants
40 39 79
1.Primary Outcome
Title Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)
Hide Description 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)
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description:
These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1 drop per study eye three times per day for 30 days plus standard care
Overall Number of Participants Analyzed 40 39
Mean (95% Confidence Interval)
Unit of Measure: microns
2.78
(-10.12 to 15.68)
5.6
(-8.2 to 19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Nepafenac
Comments The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.
Statistical Test of Hypothesis P-Value 0.7029
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.82
Confidence Interval (2-Sided) 95%
-3.27 to 8.91
Parameter Dispersion
Type: Standard Deviation
Value: 13.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pre-operative Best Corrected Visual Acuity (BCVA)
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description:
These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1 drop per study eye three times per day for 30 days plus standard care
Overall Number of Participants Analyzed 40 39
Mean (Standard Deviation)
Unit of Measure: letters
38.48  (9.83) 40.49  (9.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Nepafenac
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1937
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.01
Confidence Interval (2-Sided) 95%
-2.41 to 6.43
Parameter Dispersion
Type: Standard Deviation
Value: 9.56
Estimation Comments [Not Specified]
3.Primary Outcome
Title Foveal Thickness
Hide Description difference in mean pre-post changes by the two treatment groups
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description:
These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1 drop per study eye three times per day for 30 days plus standard care
Overall Number of Participants Analyzed 40 39
Mean (95% Confidence Interval)
Unit of Measure: microns
-2.0
(-25.4 to 21.4)
4.7
(-14.9 to 24.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Nepafenac
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5066
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.70
Confidence Interval (2-Sided) 95%
-3.12 to 16.52
Parameter Dispersion
Type: Standard Deviation
Value: 19.6
Estimation Comments [Not Specified]
4.Primary Outcome
Title Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)
Hide Description [Not Specified]
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description:
These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1 drop per study eye three times per day for 30 days plus standard care
Overall Number of Participants Analyzed 40 39
Mean (95% Confidence Interval)
Unit of Measure: microns
0.05
(-0.46 to 0.56)
0.10
(-0.11 to 0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Nepafenac
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5099
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.13 to 0.227
Parameter Dispersion
Type: Standard Deviation
Value: 0.21
Estimation Comments [Not Specified]
5.Primary Outcome
Title Post-operative Best Corrected Visual Acuity (BCVA)
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description:
These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
1 drop per study eye three times per day for 30 days plus standard care
Overall Number of Participants Analyzed 40 39
Mean (95% Confidence Interval)
Unit of Measure: letters
54.46
(39 to 67)
55.49
(44 to 65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment, Nepafenac
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5005
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
-1.49 to 3.55
Parameter Dispersion
Type: Standard Deviation
Value: 5.64
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and/or other adverse Events were not collected for this study.
 
Arm/Group Title Standard Treatment Nepafenac
Hide Arm/Group Description These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. 1 drop per study eye three times per day for 30 days plus standard care
All-Cause Mortality
Standard Treatment Nepafenac
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Treatment Nepafenac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Treatment Nepafenac
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kennth L. Cohen, MD
Organization: University of North Carolina at Chapel Hill
Phone: 919 843-0292
EMail: klc@med.unc.edu
Layout table for additonal information
Responsible Party: Kenneth Cohen, MD, UNC Chapel Hill
ClinicalTrials.gov Identifier: NCT00494494     History of Changes
Other Study ID Numbers: 05-3115
First Submitted: June 28, 2007
First Posted: June 29, 2007
Results First Submitted: April 11, 2011
Results First Posted: July 12, 2011
Last Update Posted: July 12, 2011