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The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

NCT ID: NCT00730938

Last Updated: 2008-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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The study investigates whether using an antibiotic (cefuroxime) in the anterior chamber of the eye at the end of surgery for cataract in children will reduce the amount of fibrin formation.

Conditions

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Cataract Endophthalmitis

Keywords

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fibrin endophthalmitis cataract extraction Lens implantation, intraocular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

cefuroxime

Intervention Type DRUG

intracameral cefuroxime 0.1 ml

2

Saline placebo

Group Type PLACEBO_COMPARATOR

Saline placebo

Intervention Type DRUG

0.1 ml of Ringers lactate

Interventions

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cefuroxime

intracameral cefuroxime 0.1 ml

Intervention Type DRUG

Saline placebo

0.1 ml of Ringers lactate

Intervention Type DRUG

Other Intervention Names

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Zinacef Saline

Eligibility Criteria

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Inclusion Criteria

* bilateral congenital or developmental pediatric cataract

Exclusion Criteria

* traumatic cataract
Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Presbyterian Church East Africa Kikuyu Hospital

OTHER

Sponsor Role lead

Responsible Party

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Presbyterian Church East Africa Kikuyu Hospital

Principal Investigators

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Dan Gradin, MD

Role: PRINCIPAL_INVESTIGATOR

PCEA Kikuyu Hospital

Locations

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Presbyterian Church East Africa Kikuyu Hospital

Kikuyu, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 20438039 (View on PubMed)

Other Identifiers

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Kikuyu01

Identifier Type: -

Identifier Source: org_study_id