Cataract surgery and inflammation – the role for preoperative NSAIDs (pre-CIN)

Phase 1

• Conditions: Cataract surgery, and the medical treatment is anti-inflammatory eye drops to treat (and prevent) intraocular inflammation and development og cystoid macular edema.; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-003407-34-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-29
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Participants are eligible to be included in the study if all of the following criteria apply:
•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
•Contraindications for use of any medication (e.g. allergy, pregnancy, breastfeeding)
oPregnancy is considered an exclusion criterion and pregnancy and contraception are commented in more detail in section 8.5
•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 clinical trial of medicinal product
• Study Design: Not specified