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Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nepafenac 0.3% | Experimental | nepafenac 0.3% ophthalmic solution dosed once daily |
|
| Saline Solution | Placebo Comparator | sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac 0.3% | Drug |
| ||
| Saline Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Clinical Findings of Cystoid Macular Edema | post-operative macular volume (mm) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean McCafferty, MD | Arizona Eye Consultants | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28219426 | Derived | McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nepafenac 0.3% | nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3% |
| FG001 | Saline Solution | sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Six hundred and sixty two (662) patients, one thousand eyes (1000), completed the study. 1:1 ratio of control: treatment. Subjects were chosen from patients who had visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
| ID | Title | Description |
|---|---|---|
| BG000 | Nepafenac 0.3% | nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3% |
| BG001 | Saline Solution | sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post-operative Clinical Findings of Cystoid Macular Edema | post-operative macular volume (mm) | Posted | Mean | Standard Deviation | mm | 6 weeks | Eyes | Eyes |
|
|
3 weeks
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign, symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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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 | Nepafenac 0.3% | nepafenac 0.3% ophthalmic solution dosed once daily Nepafenac 0.3% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drop intolerance | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean McCafferty, MD | Arizona Eye Consultants | 520-327-3487 | sjmccafferty66@hotmail.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Macular volume | Mean | Standard Deviation | mm | Participants |
|
| Participants |
|
| Eyes |
|
|
| 0 |
| 331 |
| 1 |
| 331 |
| EG001 | Saline Solution | sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Saline Solution | 0 | 331 | 0 | 331 |
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