Status:
UNKNOWN
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
Lead Sponsor:
Oslo University Hospital
Conditions:
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 postoperat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05331690
Start Date
November 25 2022
End Date
December 1 2023
Last Update
December 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Ophthalmology, Oslo University Hospital
Oslo, Norway