Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hamish McKee

ORCID ID

Contact details

Hull & East Yorkshire Eye Hospital
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Hamish.Mckee@hey.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084132811

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the risk of toxicity by determining the incidence of Cystoid Macular Oedema (CMO) when intraocular Cefuroxime is used at the end of cataract surgery and comparing this incidence when it is not used.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Cataract

Intervention

120 patients, aged above 50 years having cataract surgery, 60 of which will receive intraocular cefuroxime, and 60 of which will not receive intraocular cefuroxime.

Intervention type

Drug

Phase

Not Specified

Drug names

Cefuroxime

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/09/2003

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

120 patients, aged above 50 years having cataract surgery.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

19/09/2003

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull & East Yorkshire Eye Hospital
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16039491

Publication citations

  1. Results

    Gupta MS, McKee HD, Saldaña M, Stewart OG, Macular thickness after cataract surgery with intracameral cefuroxime., J Cataract Refract Surg, 2005, 31, 6, 1163-1166, doi: 10.1016/j.jcrs.2004.10.074.

Additional files

Editorial Notes