Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)

Study Overview
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Brief Summary
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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.

Official Title
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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 (Pre-CIN).

Conditions
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Cataract Surgery

Intervention / Treatment
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* Drug: Nepafenac Ophthalmic
* Drug: Nepafenac Ophthalmic
* Drug: Dexamethasone Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit. Scheduled for standard phacoemulsification cataract surgery (group 1 - 3) Scheduled for combined phacoemulsification cataract surgery and MIGS stent (group 4) Ability to cooperate fairly well during the examinations Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding) Pregnancy Diabetes Mature cataract Active or chronic uveitis with recommendation for steroid treatment Previous trabeculectomy Other ophthalmological conditions and/or complicating factors requiring steroid treatment (group 1 - 3) Cornea pathology requiring specific medication regimens (e.g. herpes pathology, previous corneal transplantation) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 NSAIDs pre<br>Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery | Drug: Nepafenac Ophthalmic<br>* Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery<br>|
| Active Comparator: Group 2 NSAIDs post<br>Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery | Drug: Nepafenac Ophthalmic<br>* Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery<br>|
| Active Comparator: Group 3 NSAIDs and steroids<br>Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery | Drug: Nepafenac Ophthalmic<br>* Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery<br>Drug: Dexamethasone Ophthalmic<br>* Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |