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CompletedNCT00730938Updated Aug 8, 2008

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

An interventional study of cefuroxime and Saline placebo in Cataract and Endophthalmitis, sponsored by Presbyterian Church East Africa Kikuyu Hospital. Completed at 1 site in Kenya. Open to participants aged 6 Months to 15 Years. Per ClinicalTrials.gov, last updated 2008-08-08.

Sponsored by Presbyterian Church East Africa Kikuyu Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
6 Months to 15 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cataract
  • Endophthalmitis

Keywords

  • fibrin
  • endophthalmitis
  • cataract extraction
  • Lens
  • implantation,
  • intraocular
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In context

Endophthalmitis

55 studies on the registry are indexed under Endophthalmitis; 8 are open to participants now.

This study's enrollment of 45 is below the median of 113 across 32 interventional studies indexed under Endophthalmitis.

Browse Endophthalmitis studies →

Lead sponsor

This is the only study on the registry with Presbyterian Church East Africa Kikuyu Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • bilateral congenital or developmental pediatric cataract

Exclusion criteria

Exclusion Criteria:

  • traumatic cataract
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    1

    Drug: cefuroxime

  • Placebo comparator
    2

    Saline placebo

    Drug: Saline placebo

Interventions

  • Drugcefuroxime

    intracameral cefuroxime 0.1 ml

    Also known as: Zinacef

  • DrugSaline placebo

    0.1 ml of Ringers lactate

    Also known as: Saline

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What researchers measure

Primary outcomes

  1. Fibrin formation in anterior chamber

    Time frame: 4th postoperative day

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Study locations

1 site
  • Presbyterian Church East Africa Kikuyu Hospital
    Kikuyu, 00902, Kenya
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References and documents

Publications

  • 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. PubMed 20438039 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00730938
Lead sponsor
Presbyterian Church East Africa Kikuyu Hospital
First posted
Aug 8, 2008
Start date
Feb 2008
Primary completion
Jul 2008
Completion
Aug 2008
Last update
Aug 8, 2008

Study contacts

Dan Gradin, MD
principal investigator · PCEA Kikuyu Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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