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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730938
• Other study ID #: Kikuyu01
• Status: Completed
• Phase: N/A
• First received: August 5, 2008
• Last updated: August 7, 2008
• Start date: February 2008
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: Presbyterian Church East Africa Kikuyu Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 15 Years

Eligibility

Inclusion Criteria:

• bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

• traumatic cataract

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Endophthalmitis

Intervention

Drug:
• cefuroxime
intracameral cefuroxime 0.1 ml
• Saline placebo
0.1 ml of Ringers lactate

Locations

Country	Name	City	State
Kenya	Presbyterian Church East Africa Kikuyu Hospital	Kikuyu

Sponsors (1)

Lead Sponsor	Collaborator
Presbyterian Church East Africa Kikuyu Hospital

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrin formation in anterior chamber		4th postoperative day	No