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

NCT05331690 | Unknown Phase 4

• 2 other identifiers: 939442020-003407-34
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Intraocular inflammation

  Preoperatively, and 1 week, 6 weeks, 6 months after surgery

• Visual outcome

  Preoperatively, and 1 week, 6 weeks, 6 months after surgery

• Intraocular pressure

  Preoperatively, and 1 week, 6 weeks, 6 months after surgery

• Central macular thickness (CMT)

  Preoperatively, 1 week, and 6 months after surgery

• Cystoid macular edema (CME)

  Preoperatively, 1 week, and 6 months after surgery

Study Arms (3)

Group 1 NSAIDs pre

ACTIVE COMPARATOR

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

Drug: Nepafenac Ophthalmic

Group 2 NSAIDs post

ACTIVE COMPARATOR

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

Drug: Nepafenac Ophthalmic

Group 3 NSAIDs and steroids

ACTIVE COMPARATOR

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

Drug: Nepafenac Ophthalmic; Drug: Dexamethasone Ophthalmic

Interventions

Nepafenac Ophthalmic DRUG

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

Group 1 NSAIDs pre

Dexamethasone Ophthalmic DRUG

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

Group 3 NSAIDs and steroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Department of Ophthalmology, Oslo University Hospital

Oslo, Norway

RECRUITING

Study Officials

• Olav Kristianslund, MD PhD

  Department of Ophthalmology, Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olav Kristianslund, MD PhD

CONTACT

+4722118545; olakri@ous-hf.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of section / Senior consultant MD PhD

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 18, 2022
• Study Start: November 25, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

NO (1)