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Trial record 20 of 25 for:    "Lens Disease" | "Nepafenac"

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

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ClinicalTrials.gov Identifier: NCT02084576
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia

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.

Condition or disease Intervention/treatment Phase
Cystoid Macular Edema Cataract Drug: Nepafenac Drug: Ketorolac Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

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
Other Name: Nevanac

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
Other Name: Acular LS




Primary Outcome Measures :
  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 Outcome Measures :
  1. Postoperative corrected distance visual acuity [ Time Frame: 4 weeks after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02084576


Locations
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Brazil
Hospital Oftalmologico de Brasília
Brasilia, DF, Brazil, 70000
Sponsors and Collaborators
Hospital Oftalmologico de Brasilia
Investigators
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Principal Investigator: Patrick F Tzelikis, MD, PhD Hospital Oftalmologico de Brasilia

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PATRICK FRENSEL DE MORAES TZELIKIS, Principal Investigator, Hospital Oftalmologico de Brasilia
ClinicalTrials.gov Identifier: NCT02084576     History of Changes
Other Study ID Numbers: 2014.02
HOB03022014 ( Other Identifier: HOB-14/02 )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014
Keywords provided by PATRICK FRENSEL DE MORAES TZELIKIS, Hospital Oftalmologico de Brasilia:
Cystoid macular edema
nonsteroidal anti-inflammatory drug
OCT
phacoemulsification.
Additional relevant MeSH terms:
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Lens Diseases
Nepafenac
Cataract
Macular Edema
Edema
Signs and Symptoms
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action