NCT00730938

Brief Summary

The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

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

February 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

Enrollment Period

5 months

First QC Date

August 5, 2008

Last Update Submit

August 7, 2008

Conditions

CataractEndophthalmitis

Keywords

fibrinendophthalmitiscataract extractionLensimplantation,intraocular

Outcome Measures

Primary Outcomes (1)

  • Fibrin formation in anterior chamber

    4th postoperative day

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: cefuroxime

2

PLACEBO COMPARATOR

Saline placebo

Drug: Saline placebo

Interventions

cefuroximeDRUG

intracameral cefuroxime 0.1 ml

Also known as: Zinacef
1
Saline placeboDRUG

0.1 ml of Ringers lactate

Also known as: Saline
2

Eligibility Criteria

Age6 Months - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • bilateral congenital or developmental pediatric cataract

You may not qualify if:

  • traumatic cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Presbyterian Church East Africa Kikuyu Hospital

Kikuyu, 00902, Kenya

Location

Related Publications (1)

  • Gradin D, Mundia D. Effect of intracameral cefuroxime on fibrinous uveitis after pediatric cataract surgery. J Pediatr Ophthalmol Strabismus. 2011 Jan-Feb;48(1):45-9. doi: 10.3928/01913913-20100420-03. Epub 2010 Apr 22.

    PMID: 20438039DERIVED

MeSH Terms

Conditions

CataractEndophthalmitis

Interventions

CefuroximeSodium Chloride

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesEye InfectionsInfections

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Dan Gradin, MD

    PCEA Kikuyu Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

KE(1)