- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730938
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
August 7, 2008 updated by: Presbyterian Church East Africa Kikuyu Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kikuyu, Kenya, 00902
- Presbyterian Church East Africa Kikuyu Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- bilateral congenital or developmental pediatric cataract
Exclusion Criteria:
- traumatic cataract
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
|
intracameral cefuroxime 0.1 ml
Other Names:
|
Placebo Comparator: 2
Saline placebo
|
0.1 ml of Ringers lactate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fibrin formation in anterior chamber
Time Frame: 4th postoperative day
|
4th postoperative day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dan Gradin, MD, PCEA Kikuyu Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
August 5, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 8, 2008
Study Record Updates
Last Update Posted (Estimate)
August 8, 2008
Last Update Submitted That Met QC Criteria
August 7, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kikuyu01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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