Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
Information source: Hospital Oftalmologico de Brasilia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystoid Macular Edema; Cataract
Intervention: Nepafenac (Drug); Ketorolac (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hospital Oftalmologico de Brasilia Official(s) and/or principal investigator(s): Patrick F Tzelikis, MD, PhD, Principal Investigator, Affiliation: Hospital Oftalmologico de Brasilia
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.
Clinical Details
Official title: Comparison of Ketorolac Tromethamine 0.4% and Nepafenac 0.1% for the Prevention of Cystoid Macular Edema After Phacoemulsification: Prospective Randomized Double-masked Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT)
Secondary outcome: Postoperative corrected distance visual acuity
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Hospital Oftalmologico de BrasÃlia, Brasilia, DF 70000, Brazil
Additional Information
Starting date: August 2013
Last updated: March 10, 2014
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