| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN91792333 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0141187727 |
| Public title | Perioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Eye Diseases: Diabetic macular oedema |
| Study hypothesis | Does triamcinolone injected into the eye at the end of cataract surgery improve visual outcome for diabetic patients who have swelling of the retina at the time of cataract surgery? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with Diabetic Mellitus, Type 1 or 2 Eligible
2. Patients with cataract sufficient in an eye to cause visual symptoms
3. Patients who have persistent CSME despite previous later treatment
4. Patients who have moderate or severs NPDR and treated PDR as defined by a clinical modification of the Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy scale
5. OCT measurements of <300 micron at central subfold of fats macula map |
| Participants - exclusion criteria | 1. Patients with no CSME
2. High risk proliferative retinopathy as defined by the DRS 17
3. Diabetes associated with specific genetic conditions, induced by drugs, chemicals or endocrinopathies
4. Coexistent ocular disease
5. Coexistent disease likely to affect retinopathy progression, for example severe carotid occlusive disease
6. Patients with coexistent disease likely to respond poorly to side effects of intravitreal triamcinalone, including glaucoma, OHT, steroid responders
7. Prior intraocular surgery to either eye
8. Complicated cataract surgery |
| Patient information material |
|
| Anticipated start date | 28/02/2007 |
| Anticipated end date | 31/08/2008 |
| Status of trial | Ongoing |
| Target number of participants | 56 (28 patients; 28 controls) |
| Interventions | Triamcinolone vs no triamcinolone |
| Primary outcome measure(s) | Macular oedema at 1 year |
| Secondary outcome measure(s) | 1. Visual acuity at 1 year
2. Macular thickness/volume
3. Retinopathy progression
4. Capsular opacification
5. Macular ischaemia |
| Sources of funding | Moorfields Eye Hospital NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Roger Wong |
| Contact details | Moorfields Eye Hospital
162 City Road
London
United Kingdom
EC1V 2PD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN91792333 |
| Date last extracted from ISRCTN register | 17/04/2008 |
