Clinical trial NCT05331690: Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
Official title: 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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract Surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Central macular thickness after 6 weeks
timeFrame: 6 weeks after surgery
measure: Cystoid macular edema (CME) after 6 weeks
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Intraocular inflammation
timeFrame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
measure: Visual outcome
timeFrame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
measure: Intraocular pressure
timeFrame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
measure: Central macular thickness (CMT)
timeFrame: Preoperatively, 1 week, and 6 months after surgery
measure: Cystoid macular edema (CME)
timeFrame: Preoperatively, 1 week, and 6 months after surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Ophthalmology, Oslo University Hospital
Study officials:
affiliation: Department of Ophthalmology, Oslo University Hospital
name: Olav Kristianslund, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: