NCT02084576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

Same day

First QC Date

February 18, 2014

Last Update Submit

March 10, 2014

Conditions

Cystoid Macular EdemaCataract

Keywords

Cystoid macular edemanonsteroidal anti-inflammatory drugOCTphacoemulsification.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postoperative corrected distance visual acuity

    4 weeks after surgery

Study Arms (2)

Nepafenac

EXPERIMENTAL

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

Drug: Nepafenac

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac

Interventions

NepafenacDRUG

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

Also known as: Nevanac
Nepafenac
KetorolacDRUG

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

Also known as: Acular LS
Ketorolac

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 40 years with age-related cataract, and a normal ophthalmologic examination besides senile cataract.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Oftalmologico de Brasília

Brasília, Federal District, 70000, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 21187730RESULT

  • 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.

    PMID: 20216291RESULT

  • 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.

    PMID: 18165083RESULT

  • 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.

    PMID: 25385061DERIVED

MeSH Terms

Conditions

Macular EdemaCataract

Interventions

nepafenacKetorolac

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Patrick F Tzelikis, MD, PhD

    Hospital Oftalmologico de Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2014

First Posted

March 12, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

February 1, 2014

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

BR(1)