Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
Primary Purpose
Cystoid Macular Edema, Cataract
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Nepafenac
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Cystoid Macular Edema focused on measuring Cystoid macular edema, nonsteroidal anti-inflammatory drug, OCT, phacoemulsification.
Eligibility 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
Sites / Locations
- Hospital Oftalmologico de Brasília
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nepafenac
Ketorolac
Arm Description
One drop in the study eye 3 times daily for 30 days
One drop in the study eye 4 times daily for 30 days
Outcomes
Primary Outcome Measures
The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT)
Secondary Outcome Measures
Postoperative corrected distance visual acuity
Full Information
NCT ID
NCT02084576
First Posted
February 18, 2014
Last Updated
March 10, 2014
Sponsor
Hospital Oftalmologico de Brasilia
1. Study Identification
Unique Protocol Identification Number
NCT02084576
Brief Title
Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Oftalmologico de Brasilia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystoid Macular Edema, Cataract
Keywords
Cystoid macular edema, nonsteroidal anti-inflammatory drug, OCT, phacoemulsification.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nepafenac
Arm Type
Experimental
Arm Description
One drop in the study eye 3 times daily for 30 days
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
One drop in the study eye 4 times daily for 30 days
Intervention Type
Drug
Intervention Name(s)
Nepafenac
Other Intervention Name(s)
Nevanac
Intervention Description
One drop in the study eye 3 times daily for 30 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Acular LS
Intervention Description
One drop in the study eye 4 times daily for 30 days
Primary Outcome Measure Information:
Title
The incidence of CME was evaluated by retinal foveal thickness on optical coherence tomography (OCT)
Time Frame
After 1 week, 4 weeks, 12 weeks after surgery
Secondary Outcome Measure Information:
Title
Postoperative corrected distance visual acuity
Time Frame
4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick F Tzelikis, MD, PhD
Organizational Affiliation
Hospital Oftalmologico de Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Oftalmologico de Brasília
City
Brasilia
State/Province
DF
ZIP/Postal Code
70000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
21187730
Citation
Shelsta HN, Jampol LM. Pharmacologic therapy of pseudophakic cystoid macular edema: 2010 update. Retina. 2011 Jan;31(1):4-12. doi: 10.1097/IAE.0b013e3181fd9740.
Results Reference
result
PubMed Identifier
20216291
Citation
Brar M, Yuson R, Kozak I, Mojana F, Cheng L, Bartsch DU, Oster SF, Freeman WR. Correlation between morphologic features on spectral-domain optical coherence tomography and angiographic leakage patterns in macular edema. Retina. 2010 Mar;30(3):383-9. doi: 10.1097/IAE.0b013e3181cd4803.
Results Reference
result
PubMed Identifier
18165083
Citation
Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg. 2008 Jan;34(1):64-9. doi: 10.1016/j.jcrs.2007.08.034.
Results Reference
result
PubMed Identifier
25385061
Citation
Tzelikis PF, Vieira M, Hida WT, Motta AF, Nakano CT, Nakano EM, Alves MR. Comparison of ketorolac 0.4% and nepafenac 0.1% for the prevention of cystoid macular oedema after phacoemulsification: prospective placebo-controlled randomised study. Br J Ophthalmol. 2015 May;99(5):654-8. doi: 10.1136/bjophthalmol-2014-305803. Epub 2014 Nov 10.
Results Reference
derived
Learn more about this trial
Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
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