Cataract Surgery
Conditions
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.
Interventions
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | Preoperatively, and 1 week, 6 weeks, 6 months after surgery | Measured by tonometry |
| Intraocular inflammation | Preoperatively, and 1 week, 6 weeks, 6 months after surgery | Measured by laser flare meter |
| 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) |
| Central macular thickness (CMT) | Preoperatively, 1 week, and 6 months after surgery | Measure CMT (in um) on optical coherence tomography (OCT) |
| Visual outcome | Preoperatively, and 1 week, 6 weeks, 6 months after surgery | Measure uncorrected and corrected distance visual acuity using visual acuity chart |
Countries
Norway
Contacts
Primary ContactOlav Kristianslund, MD PhD
Outcome results
None listed