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

Sponsored by:	Presbyterian Church East Africa Kikuyu Hospital
Information provided by:	Presbyterian Church East Africa Kikuyu Hospital
ClinicalTrials.gov Identifier:	NCT00730938

Purpose

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.

Condition	Intervention
Cataract Endophthalmitis	Drug: cefuroxime Drug: Saline placebo

MedlinePlus related topics: Antibiotics Cataract

Drug Information available for: Cefuroxime Cefuroxime axetil Cefuroxime sodium Lactic acid Ammonium lactate Fibrin Ringer's lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

Further study details as provided by Presbyterian Church East Africa Kikuyu Hospital:

Primary Outcome Measures:

Fibrin formation in anterior chamber [ Time Frame: 4th postoperative day ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	February 2008
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: cefuroxime intracameral cefuroxime 0.1 ml
2: Placebo Comparator Saline placebo	Drug: Saline placebo 0.1 ml of Ringers lactate

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.

Eligibility

Ages Eligible for Study:	6 Months to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

traumatic cataract

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730938

Locations

Kenya
Presbyterian Church East Africa Kikuyu Hospital
Kikuyu, Kenya, 00902

Sponsors and Collaborators

Presbyterian Church East Africa Kikuyu Hospital

Investigators

Principal Investigator:

Dan Gradin, MD

PCEA Kikuyu Hospital

More Information

Responsible Party:	Presbyterian Church East Africa Kikuyu Hospital ( Dan Gradin, MD )
Study ID Numbers:	Kikuyu01
Study First Received:	August 5, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730938
Health Authority:	Kenya: Institutional Review Board

Keywords provided by Presbyterian Church East Africa Kikuyu Hospital:

fibrin
endophthalmitis
cataract extraction

Lens
implantation,
intraocular

Study placed in the following topic categories:

Bacterial Infections
Mycoses
Eye Infections, Bacterial
Cefuroxime axetil
Cefuroxime
Uveitis

Eye Diseases
Cataract
Eye Infections
Endophthalmitis
Suppuration
Lens Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Uveal Diseases
Therapeutic Uses

Uveitis, Suppurative
Eye Infections, Fungal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009