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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Cataract Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 NSAIDs pre

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

Group Type ACTIVE_COMPARATOR

Nepafenac Ophthalmic

Intervention Type DRUG

Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery

Group 2 NSAIDs post

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

Group Type ACTIVE_COMPARATOR

Nepafenac Ophthalmic

Intervention Type DRUG

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

Group 3 NSAIDs and steroids

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

Group Type ACTIVE_COMPARATOR

Nepafenac Ophthalmic

Intervention Type DRUG

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

Dexamethasone Ophthalmic

Intervention Type DRUG

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Interventions

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Nepafenac Ophthalmic

Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery

Intervention Type DRUG

Nepafenac Ophthalmic

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

Intervention Type DRUG

Dexamethasone Ophthalmic

Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No