search
Back to results

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

Primary Purpose

Cataract, Endophthalmitis

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
cefuroxime
Saline placebo
Sponsored by
Presbyterian Church East Africa Kikuyu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring fibrin, endophthalmitis, cataract extraction, Lens, implantation,, intraocular

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

  • traumatic cataract

Sites / Locations

  • Presbyterian Church East Africa Kikuyu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Saline placebo

Outcomes

Primary Outcome Measures

Fibrin formation in anterior chamber

Secondary Outcome Measures

Full Information

First Posted
August 5, 2008
Last Updated
August 7, 2008
Sponsor
Presbyterian Church East Africa Kikuyu Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00730938
Brief Title
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Official Title
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Presbyterian Church East Africa Kikuyu Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Endophthalmitis
Keywords
fibrin, endophthalmitis, cataract extraction, Lens, implantation,, intraocular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Saline placebo
Intervention Type
Drug
Intervention Name(s)
cefuroxime
Other Intervention Name(s)
Zinacef
Intervention Description
intracameral cefuroxime 0.1 ml
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
Saline
Intervention Description
0.1 ml of Ringers lactate
Primary Outcome Measure Information:
Title
Fibrin formation in anterior chamber
Time Frame
4th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bilateral congenital or developmental pediatric cataract Exclusion Criteria: traumatic cataract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Gradin, MD
Organizational Affiliation
PCEA Kikuyu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Presbyterian Church East Africa Kikuyu Hospital
City
Kikuyu
ZIP/Postal Code
00902
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
20438039
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs