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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00730938
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cataract Endophthalmitis Drug: cefuroxime Drug: Saline placebo

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Study Start Date : February 2008
Primary Completion Date : July 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Fibrin formation in anterior chamber [ Time Frame: 4th postoperative day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

  • traumatic cataract
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008

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

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