Contact information
Type
Scientific
Primary contact
Mr S B Kaye
ORCID ID
Contact details
St Pauls Eye Unit
8Z Link
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
+44 (0)151 706 2134
Stephen.kaye@rlbuht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0207129695
Study information
Scientific title
Acronym
Study hypothesis
Does ketamine reduce post-operative cystoid macula oedema in patients who undergo cataract surgery?
Ethics approval
Not provided at time of registration
Study design
Prospective, randomised, parallel group, double blind, clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Cataract
Intervention
Group A receive ketamine under general anaesthetic
Group B receive general anaesthetic without ketamine
Group C receive local anaesthetic without ketamine
Intervention type
Drug
Phase
Not Specified
Drug names
ketamine
Primary outcome measures
To define population for definitive randomised prospective trial on effects of ketamine on cystoid macula oedema in patients undergoing cataract surgery
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2004
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Pilot study; 3 groups of 11.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2004
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Pauls Eye Unit
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Liverpool and Broadgreen University Hospitals Trust (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
2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17653058
Publication citations
-
Results
Tu KL, Kaye SB, Sidaras G, Taylor W, Shenkin A, Effect of intraocular surgery and ketamine on aqueous and serum cytokines., Mol. Vis., 2007, 13, 1130-1137.