CataractNCT00730938
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
A study testing cefuroxime in people with Cataract and Endophthalmitis, run by Presbyterian Church East Africa Kikuyu Hospital at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Cataract, Endophthalmitis
- What is being tested?
- cefuroxime
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- bilateral congenital or developmental pediatric cataract
Who cannot join
- traumatic cataract
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cataract, Endophthalmitis
- Being tested
- cefuroxime, Saline placebo
- Keywords
- fibrin, endophthalmitis, cataract extraction, Lens, implantation,, intraocular
- Medical subject headings
- Cataract, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefuroximeDrug
Also called Zinacef
intracameral cefuroxime 0.1 ml
Saline placeboDrug
Also called Saline
0.1 ml of Ringers lactate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: cefuroxime |
| 2 | Placebo comparator | Saline placebo Receives: Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibrin formation in anterior chamber
Measured: 4th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presbyterian Church East Africa Kikuyu Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dan Gradin, MD, Principal investigator, PCEA Kikuyu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730938
- Sponsor's protocol ID
- Kikuyu01
- Status last verified
- Aug 2008
- First submitted
- 5 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
- ClinicalTrials.gov ID
- NCT00730938
- Acronym / sponsor ID
- Kikuyu01
- Conditions
- Cataract, Endophthalmitis
- Keywords
- fibrin, endophthalmitis, cataract extraction, Lens, implantation,, intraocular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Presbyterian Church East Africa Kikuyu HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: cefuroxime |
| 2 | Placebo comparator | Drug: Saline placeboSaline placebo |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- bilateral congenital or developmental pediatric cataract
Key exclusion criteria (1 listed)
- traumatic cataract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefuroximeAlso: Zinacefintracameral cefuroxime 0.1 ml | Drug | 1 |
| Saline placeboAlso: Saline0.1 ml of Ringers lactate | Drug | 2 |
Primary outcome
Fibrin formation in anterior chamber
Time frame: 4th postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 20438039Gradin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Gradin, MD principal investigator
PCEA Kikuyu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cefuroxime in people with Cataract and Endophthalmitis, run by Presbyterian Church East Africa Kikuyu Hospital at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrin formation in anterior chamber (time frame: 4th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.