Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/02/2008
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

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

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

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

  1. 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.

Additional files

Editorial Notes