Prevention of post-cataract surgery macula oedema with prophylactic ketorolac
| ISRCTN | ISRCTN02628492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02628492 |
| Protocol serial number | 1.2 |
| Sponsor | Frimley Park Hospital NHS Foundation Trust (UK) |
| Funder | Frimley Park Hospital NHS Foundation Trust (UK) - Ophthalmology Research Funding will cover any extra costs incurred |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prevention of pseudophakic cystoid macula oedema with pre- and post-operative ketorolac |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Ketorolac |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Logarithmic minimal angle of resolution (LogMAR) visual acuity |
| Completion 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 sample size at registration | 1400 |
| Key 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. |
| Key exclusion criteria | 1. Patients who have previously had a reaction to ketorolac 2. Patients who are on systemic non-steroidal anti-inflammatories or steroids |
| Date of first enrolment | 12/07/2008 |
| Date of final enrolment | 12/10/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Frimley Park Hospital NHS Foundation Trust
Frimley
GU16 7UJ
United Kingdom
GU16 7UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
