Condition category
Eye Diseases
Date applied
06/07/2008
Date assigned
22/07/2008
Last edited
10/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Geeta Menon

ORCID ID

Contact details

Frimley Park Hospital NHS Foundation Trust
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2

Study information

Scientific title

Prevention of pseudophakic cystoid macula oedema with pre- and post-operative ketorolac

Acronym

Study hypothesis

To assess whether patients treated with ketorolac 3 days pre- and 3 weeks post-operatively in combination with post-operative steroid drops have a lower incidence of cystoid macula oedema (CMO) following cataract surgery than those receiving standard clinical care (pre-operative topical flurbiprofen 1 hour prior to surgery and post-operative steroid drops).

Ethics approval

Ethics approval pending as of 07/07/2008. London-Surrey Borders ethics committee will be meeting on 9th July 2008.

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cystoid macular oedema (CMO)

Intervention

1. Intervention: ketorolac eye drops (0.4%) - 1 eye drop 4 times a day for 3 days before the operation and 3 weeks after the operation
2. Control arm: usual clinical care - 1 drop of flurbiprofen eye drop 1 hour before surgery and Maxidex® eye drop three times a day for 3 weeks post-cataract surgery

Intervention type

Drug

Phase

Not Specified

Drug names

Ketorolac

Primary outcome measures

Central macula thickness as measured on optical coherence tomography at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.

Secondary outcome measures

1. Logarithmic minimal angle of resolution (LogMAR) visual acuity
2. Contrast sensitivity
3. Adverse events

The secondary outcomes will be measured at baseline (prior to surgery), 1 month after surgery, 2 months after surgery and 3 months after surgery.

Overall trial start date

12/07/2008

Overall trial end date

12/10/2009

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Patients undergoing routine cataract surgery without an additional procedure
2. Patients with risk factors for developing CMO, such as pre-existing diabetes
3. Aged 18 to 75 years, male and female

Patients with epiretinal membranes or age-related macular degeneration (ARMD) will be analysed separately.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1400

Participant exclusion criteria

1. Patients who have previously had a reaction to ketorolac
2. Patients who are on systemic non-steroidal anti-inflammatories or steroids

Recruitment start date

12/07/2008

Recruitment end date

12/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Frimley Park Hospital NHS Foundation Trust
Frimley
GU16 7UJ
United Kingdom

Sponsor information

Organisation

Frimley Park Hospital NHS Foundation Trust (UK)

Sponsor details

Portsmouth Road
Frimley
GU16 7UJ
United Kingdom

Sponsor type

Government

Website

http://www.frimleypark.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Frimley Park Hospital NHS Foundation Trust (UK) - Ophthalmology Research Funding will cover any extra costs incurred

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

Publication citations

Additional files

Editorial Notes

10/05/2016: This trial was terminated on 29/09/2010 due to inability to obtain additional funding required to proceed with the trial.