Submission date
12/09/2003
Registration date
12/09/2003
Last edited
31/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Dr Douglas Newman

ORCID ID

Contact details

Box No 41
Department of Ophthalmology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 245151 (x 2701)
abc@email.com

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N0287023319

Study information

Scientific title

Comparison of topical keturolac versus dexamethasone after vitreo-retinal surgery

Acronym

Study hypothesis

The aim of the study is to determine if topical ketorulac has equal anti-inflammatory efficacy to dexamethasone with fewer adverse effects (specifically steroid-induced glaucoma).

Ethics approval(s)

Not provided at time of registration

Study design

Prospective randomised double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

Surgery: Vitreo-retinal

Intervention

Prospective, randomised, double blind study comparing topical keturolac to dexamethasone as post-operative anti-inflammatory medication following vitreo-retinal surgery.

Intervention type

Drug

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Keturolac, dexamethasone

Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall study start date

02/04/1998

Overall study end date

19/06/2003

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type(s)

Patient

Age group

Not Specified

Sex

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

02/04/1998

Recruitment end date

19/06/2003

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Cambridge Consortium - Addenbrooke's (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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.