Prevention of post-cataract surgery macula oedema with prophylactic ketorolac
| ISRCTN | ISRCTN02628492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02628492 |
| Secondary identifying numbers | 1.2 |
- Submission date
- 06/07/2008
- Registration date
- 22/07/2008
- Last edited
- 10/05/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mrs Geeta Menon
Scientific
Scientific
Frimley Park Hospital NHS Foundation Trust
Portsmouth Road
Frimley
GU16 7UJ
United Kingdom
Study information
| Study design | Single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prevention of pseudophakic cystoid macula oedema with pre- and post-operative ketorolac |
| 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(s) | Ethics approval pending as of 07/07/2008. London-Surrey Borders ethics committee will be meeting on 9th July 2008. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ketorolac |
| Primary outcome measure | 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 study start date | 12/07/2008 |
| Overall study end date | 12/10/2009 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 1400 |
| 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 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
- England
- United Kingdom
Study participating centre
Frimley Park Hospital NHS Foundation Trust
Frimley
GU16 7UJ
United Kingdom
GU16 7UJ
United Kingdom
Sponsor information
Frimley Park Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Portsmouth Road
Frimley
GU16 7UJ
England
United Kingdom
| Website | http://www.frimleypark.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00mrq3p58 |
Funders
Funder type
Hospital/treatment centre
Frimley Park Hospital NHS Foundation Trust (UK) - Ophthalmology Research Funding will cover any extra costs incurred
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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.
