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

University of Oslo (UIO)

Status and phase: Enrolling; Phase 4

Conditions: Cataract Surgery

Treatments: Drug: Dexamethasone Ophthalmic; Drug: Nepafenac Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT05331690

93944

2020-003407-34 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 3 patient groups

Group 1 NSAIDs pre

Active Comparator group

Description:

Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery

Treatment:

Drug: Nepafenac Ophthalmic

Drug: Nepafenac Ophthalmic

Group 2 NSAIDs post

Active Comparator group

Description:

Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery

Treatment:

Drug: Nepafenac Ophthalmic

Drug: Nepafenac Ophthalmic

Group 3 NSAIDs and steroids

Active Comparator group

Description:

Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery

Treatment:

Drug: Nepafenac Ophthalmic

Drug: Dexamethasone Ophthalmic

Drug: Nepafenac Ophthalmic