Effect of Ketamine on post-operative intraocular inflammation following cataract surgery

ISRCTN ISRCTN84553798
DOI https://doi.org/10.1186/ISRCTN84553798
Secondary identifying numbers N0207129695
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
18/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr S B Kaye
Scientific

St Pauls Eye Unit
8Z Link
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Phone +44 (0)151 706 2134
Email Stephen.kaye@rlbuht.nhs.uk

Study information

Study designProspective, randomised, parallel group, double blind, clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDoes ketamine reduce post-operative cystoid macula oedema in patients who undergo cataract surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Cataract
InterventionGroup A receive ketamine under general anaesthetic
Group B receive general anaesthetic without ketamine
Group C receive local anaesthetic without ketamine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)ketamine
Primary outcome measureTo define population for definitive randomised prospective trial on effects of ketamine on cystoid macula oedema in patients undergoing cataract surgery
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2004
Completion date01/07/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsPilot study; 3 groups of 11.
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/02/2004
Date of final enrolment01/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Pauls Eye Unit
Liverpool
L7 8XP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Royal Liverpool and Broadgreen University Hospitals Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/07/2007 Yes No