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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Topical nepafenac (Nevanac) 3 mg/ml starter the day before surgery
Topical nepafenac (Nevanac) 3 mg/ml started the day after surgery
Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery
Department of Ophthalmology, Oslo University Hospital
Oslo, Norway
RECRUITINGCentral macular thickness after 6 weeks
Measure central macular thickness (in um) on optical coherence tomography (OCT)
Time frame: 6 weeks after surgery
Cystoid macular edema (CME) after 6 weeks
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Time frame: 6 weeks after surgery
Intraocular inflammation
Measured by laser flare meter
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Visual outcome
Measure uncorrected and corrected distance visual acuity using visual acuity chart
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Intraocular pressure
Measured by tonometry
Time frame: Preoperatively, and 1 week, 6 weeks, 6 months after surgery
Central macular thickness (CMT)
Measure CMT (in um) on optical coherence tomography (OCT)
Time frame: Preoperatively, 1 week, and 6 months after surgery
Cystoid macular edema (CME)
Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Time frame: Preoperatively, 1 week, and 6 months after surgery
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