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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02084576
Enrollment
40
Registered
2014-03-12
Start date
2013-08-31
Completion date
2014-02-28
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoid Macular Edema, Cataract

Keywords

Cystoid macular edema, nonsteroidal anti-inflammatory drug, OCT, phacoemulsification.

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.

Interventions

One drop in the study eye 3 times daily for 30 days

DRUGKetorolac

One drop in the study eye 4 times daily for 30 days

Sponsors

Hospital Oftalmologico de Brasilia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Postoperative corrected distance visual acuity4 weeks after surgery

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026