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OpenTrials
Completed

NCT Number: NCT02084576

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Oftalmologico de Brasília

Brasília, Federal District, 70000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nepafenac

Drug

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

Other names: Nevanac

Ketorolac

Drug

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

Other names: Acular LS

Primary outcomes

  1. 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 outcomes

  1. Postoperative corrected distance visual acuity

    Time frame: 4 weeks after surgery

Sponsors and collaborators

Lead sponsor

Hospital Oftalmologico de Brasilia

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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