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| Name | Class |
|---|---|
| Research to Prevent Blindness | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Active Comparator | topical antibiotic for 10 days and a topical corticosteroid for 1 month |
|
| Nepafenac | Experimental | 1 drop per study eye three times per day for 30 days in addition to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Care | Drug | topical antibiotic for 10 days plus topical corticosteroids for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 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) | baseline and 8 weeks |
| Pre-operative Best Corrected Visual Acuity (BCVA) | 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. | baseline |
| Foveal Thickness | difference in mean pre-post changes by the two treatment groups | baseline and 8 weeks |
| Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) | baseline and 8 weeks | |
| Post-operative Best Corrected Visual Acuity (BCVA) | 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. | baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth C Cohen, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. |
| FG001 | Nepafenac | 1 drop per study eye three times per day for 30 days plus standard care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. |
| BG001 | Nepafenac |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 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) | 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. | Posted | Mean | 95% Confidence Interval | microns | baseline and 8 weeks |
|
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Serious and/or other adverse Events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kennth L. Cohen, MD | University of North Carolina at Chapel Hill | 919 843-0292 | klc@med.unc.edu |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C414203 | nepafenac |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| nepafenac | Drug | liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid |
|
1 drop per study eye three times per day for 30 days plus standard care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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1 drop per study eye three times per day for 30 days plus standard care |
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| Primary | Pre-operative Best Corrected Visual Acuity (BCVA) | 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. | The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA). | Posted | Mean | Standard Deviation | letters | baseline |
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| Primary | Foveal Thickness | difference in mean pre-post changes by the two treatment groups | Posted | Mean | 95% Confidence Interval | microns | baseline and 8 weeks |
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| Primary | Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) | Posted | Mean | 95% Confidence Interval | microns | baseline and 8 weeks |
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| Primary | Post-operative Best Corrected Visual Acuity (BCVA) | 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. | Posted | Mean | 95% Confidence Interval | letters | baseline and 8 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Nepafenac | 1 drop per study eye three times per day for 30 days plus standard care | 0 | 0 | 0 | 0 |
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| D007905 |
| Lens Diseases |