The Effect of Intracameral Cefuroxime on Post-op Fibrin i... | NCT00730938

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

NCT00730938

Sponsor

Presbyterian Church East Africa Kikuyu Hospital

Status

Completed

Last Update Posted

Aug 8, 2008Estimated

Enrollment

45Actual

Phase

Not Applicable

Conditions

Cataract
Endophthalmitis

Interventions

cefuroxime
Saline placebo

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Aug 5, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2008

Last Update Posted Date

Aug 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: cefuroxime
2	Placebo Comparator	Saline placebo	Drug: Saline placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefuroxime	Drug	intracameral cefuroxime 0.1 ml	1	Zinacef

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fibrin formation in anterior chamber		4th postoperative day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

traumatic cataract

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dan Gradin, MD	PCEA Kikuyu Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Presbyterian Church East Africa Kikuyu Hospital		Kikuyu		00902	Kenya

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20438039	Derived	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D015817	Eye Infections
D007239	Infections

ID	Term
D002444	Cefuroxime
D012965	Sodium Chloride

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

ID	Term
D002386	Cataract
D009877	Endophthalmitis