Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
- Conditions
- Cataract Surgery
- Interventions
- Registration Number
- NCT05331690
- Lead Sponsor
- Oslo University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 NSAIDs pre Nepafenac Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml started 1 day before surgery Group 2 NSAIDs post Nepafenac Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery Group 3 NSAIDs and steroids Nepafenac Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery Group 3 NSAIDs and steroids Dexamethasone Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml + topical dexamethasone (Spersadex) started the day after surgery
- Primary Outcome Measures
Name Time Method Central macular thickness after 6 weeks 6 weeks after surgery Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 6 weeks 6 weeks after surgery Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
- Secondary Outcome Measures
Name Time Method Intraocular inflammation Preoperatively, and 1 week, 6 weeks, 6 months after surgery Measured by laser flare meter
Visual outcome Preoperatively, and 1 week, 6 weeks, 6 months after surgery Measure uncorrected and corrected distance visual acuity using visual acuity chart
Intraocular pressure Preoperatively, and 1 week, 6 weeks, 6 months after surgery Measured by tonometry
Central macular thickness (CMT) Preoperatively, 1 week, and 6 months after surgery Measure CMT (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) Preoperatively, 1 week, and 6 months after surgery Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Trial Locations
- Locations (1)
Department of Ophthalmology, Oslo University Hospital
🇳🇴Oslo, Norway