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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003407-34 | EudraCT Number |
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The pre-CIN trial is a randomized clinical three-arm trial comparing inflammation and cystoid macular edema for the medication regimens preoperative and postoperative topical NSAIDs to only postoperative topical NSAIDs to postoperative topical NSAIDs and steroids in patients undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 NSAIDs pre | Active Comparator | Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery |
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| Group 2 NSAIDs post | Active Comparator | Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery |
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| Group 3 NSAIDs and steroids | Active Comparator | Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac Ophthalmic | Drug | Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Central macular thickness after 6 weeks | Measure central macular thickness (in um) on optical coherence tomography (OCT) | 6 weeks after surgery |
| Cystoid macular edema (CME) after 6 weeks | Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT) | 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular inflammation | Measured by laser flare meter | Preoperatively, and 1 week, 6 weeks, 6 months after surgery |
| Visual outcome | Measure uncorrected and corrected distance visual acuity using visual acuity chart |
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Inclusion Criteria:
Exclusion Criteria:
Patients with complications or other complicating factors during surgery that causes the surgeon to demand both NSAIDs and steroid treatment will be excluded from the main analysis. These patients will be followed postoperatively as part of the study and included in additional analyses (for example as part of an intention to treat analysis).
For patients scheduled for cataract surgery in both eyes, only the first operated eye will be included, however, both eyes will be examined.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Kristianslund, MD PhD | Contact | +4722118545 | olakri@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Olav Kristianslund, MD PhD | Department of Ophthalmology, Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Oslo University Hospital | Recruiting | Oslo | Norway |
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| Nepafenac Ophthalmic | Drug | Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery |
|
| Dexamethasone Ophthalmic | Drug | Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery |
|
| Preoperatively, and 1 week, 6 weeks, 6 months after surgery |
| Intraocular pressure | Measured by tonometry | Preoperatively, and 1 week, 6 weeks, 6 months after surgery |
| Central macular thickness (CMT) | Measure CMT (in um) on optical coherence tomography (OCT) | Preoperatively, 1 week, and 6 months after surgery |
| Cystoid macular edema (CME) | Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT) | Preoperatively, 1 week, and 6 months after surgery |