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 |
| Secondary identifying numbers | N0084132811 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cefuroxime |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/09/2003 |
| Overall study end date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 120 |
| Participant inclusion criteria | 120 patients, aged above 50 years having cataract surgery. |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 19/09/2003 |
| Recruitment end date | 31/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hull & East Yorkshire Eye Hospital
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
The North and South Bank Research and Development Consortium (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2005 | Yes | No |
