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

This study has been completed.
Sponsor:
Information provided by:
Presbyterian Church East Africa Kikuyu Hospital
ClinicalTrials.gov Identifier:
NCT00730938
First received: August 5, 2008
Last updated: August 7, 2008
Last verified: August 2008
History of Changes
  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

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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

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
Active Comparator: 1 Drug: cefuroxime
intracameral cefuroxime 0.1 ml
Other Name: Zinacef
Placebo Comparator: 2
Saline placebo
 Drug: Saline placebo
0.1 ml of Ringers lactate
Other Name: Saline

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

No publications provided by Presbyterian Church East Africa Kikuyu Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Presbyterian Church East Africa Kikuyu Hospital:
fibrin
endophthalmitis
cataract extraction
 Lens
implantation,
intraocular

Additional relevant MeSH terms:
Endophthalmitis
Cataract
Eye Infections
Infection
Eye Diseases
Lens Diseases
 Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013