Randomised clinical trial to determine the incidence of Cystoid Macular Oedema (CMO) after cataract surgery with Intraocular Cefuroxime.
| ISRCTN | ISRCTN13489716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13489716 |
| Protocol serial number | N0084132811 |
| Sponsor | Department of Health |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hamish McKee
Scientific
Scientific
Hull & East Yorkshire Eye Hospital
Anlaby Road
Hull
HU3 2JZ
United Kingdom
| Hamish.Mckee@hey.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the risk of toxicity by determining the incidence of Cystoid Macular Oedema (CMO) when intraocular Cefuroxime is used at the end of cataract surgery and comparing this incidence when it is not used. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Cataract |
| Intervention | 120 patients, aged above 50 years having cataract surgery, 60 of which will receive intraocular cefuroxime, and 60 of which will not receive intraocular cefuroxime. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cefuroxime |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | 120 patients, aged above 50 years having cataract surgery. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/09/2003 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hull & East Yorkshire Eye Hospital
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
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? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2005 | Yes | No |
