Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2014 |
| First Submitted: | 02/17/2014 |
| Estimated Enrollment Submitted: | 03/09/2014 |
| First Posted: | 03/11/2014 |
| Last Update Submitted: | 03/09/2014 |
| Last Update Posted: | 03/11/2014 |
| Actual Study Start Date: | 07/31/2013 |
| Estimated Primary Completion Date: | 07/31/2013 |
| Estimated Study Completion Date: | 01/31/2014 |
Condition or disease
Intervention/treatment
Drug: Nepafenac
Drug: Ketorolac
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Nepafenac One drop in the study eye 3 times daily for 30 days | Drug: Nepafenac One drop in the study eye 3 times daily for 30 days |
| Active Comparator: Ketorolac One drop in the study eye 4 times daily for 30 days | Drug: Ketorolac One drop in the study eye 4 times daily for 30 days |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract. Exclusion Criteria: - 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 |
Outcome
Primary Outcome Measures
1. The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT) [After 1 week, 4 weeks, 12 weeks after surgery]
Secondary Outcome Measures
1. Postoperative corrected distance visual acuity [4 weeks after surgery]
