Perioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema
ISRCTN | ISRCTN91792333 |
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DOI | https://doi.org/10.1186/ISRCTN91792333 |
Secondary identifying numbers | N0141187727 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 05/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mr Roger Wong
Scientific
Scientific
Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Perioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema |
Study objectives | 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? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Eye Diseases: Diabetic macular oedema |
Intervention | Triamcinolone vs no triamcinolone |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | triamcinolone |
Primary outcome measure | Macular oedema at 1 year |
Secondary outcome measures | 1. Visual acuity at 1 year 2. Macular thickness/volume 3. Retinopathy progression 4. Capsular opacification 5. Macular ischaemia |
Overall study start date | 28/02/2007 |
Completion date | 31/08/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 56 (28 patients; 28 controls) |
Key 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 |
Key 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 |
Date of first enrolment | 28/02/2007 |
Date of final enrolment | 31/08/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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
05/02/2018: No publications found, verifying study status with principal investigator.