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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2008

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 1
  • Placebo Comparator: 2
    • Saline placebo

Clinical Trial Outcome Measures

Primary Measures

  • Fibrin formation in anterior chamber
    • Time Frame: 4th postoperative day

Participating in This Clinical Trial

Inclusion Criteria

  • bilateral congenital or developmental pediatric cataract

Exclusion Criteria

  • traumatic cataract

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Presbyterian Church East Africa Kikuyu Hospital
  • Provider of Information About this Clinical Study
    • Dan Gradin, MD, Presbyterian Church East Africa Kikuyu Hospital
  • Overall Official(s)
    • Dan Gradin, MD, Principal Investigator, PCEA Kikuyu Hospital

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