NCT02084576

Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification

Comparison of Ketorolac Tromethamine 0.4% and Nepafenac 0.1% for the Prevention of Cystoid Macular Edema After Phacoemulsification: Prospective Randomized Double-masked Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital Oftalmologico de Brasilia · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac 0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract extraction.

Detailed description

This prospective randomized clinical trial study included patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. Exclusion criteria were previous ocular surgery, central endothelial cell count less than 2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the capsular bag) were subsequently excluded. Study Protocol Preoperatively, patients had an extensive ophthalmologic examination, including measurement of corrected distance visual acuity (CDVA), refraction, slitlamp examination, intraocular pressure (IOP), fundoscopy, corneal endothelial cell count by noncontact specular microscopy (Noncon Robo, Konan), central corneal thickness (CCT) measurement (Pentacam, Oculus, Inc.), and biometry with the IOLMaster partial coherence interferometry device (Carl Zeiss Meditec AG). The targeted postoperative refractive error was 0.0 D. The visual acuity measurements were recorded with logMAR UDVA and CDVA. In addition, a baseline spectral-domain OCT (SD-OCT) scan was performed before surgery and postoperatively after 1, 4 and 12 weeks. All SD-OCT imaging was performed with a spectral-domain Heidelberg Spectralis OCT devise (Heidelberg Engineering, Inc., Heidelberg, Germany). Patients were assigned in a 1:1 ration to 1 of 2 treatments groups using a computer-generated randomization list. The study medications were ketorolac tromethamine 0.4% (Acular LS, Allergan) in group 1, and nepafenac 0.1% (Nevanac, Alcon) in group 2. Patients were instructed to instill ketorolac tromethamine 0.4% 1 drop in the operative eye 4 times a day (breakfast, lunch, dinner, and before bedtime), and nepafenac 0.1% 1 drop 3 times a day.

Conditions

• Cystoid Macular Edema
• Cataract

Interventions

Type	Name	Description
DRUG	Nepafenac	One drop in the study eye 3 times daily for 30 days
DRUG	Ketorolac	One drop in the study eye 4 times daily for 30 days

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-08-01
• Completion: 2014-02-01
• First posted: 2014-03-12
• Last updated: 2014-03-12

Locations

1 site across 1 country: Brazil