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

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract Surgery
• Intervention / Treatment: Drug: Nepafenac Ophthalmic; Drug: Nepafenac Ophthalmic; Drug: Dexamethasone Ophthalmic

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Recruiting
    • Department of Ophthalmology, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Nepafenac
• Other Study ID Numbers: 93944; 2020-003407-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No