Perioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema

ISRCTN	ISRCTN91792333
DOI	https://doi.org/10.1186/ISRCTN91792333
Secondary identifying numbers	N0141187727

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

Mr Roger Wong
Scientific

Moorfields Eye Hospital
162 City Road
London
EC1V 2PD
United Kingdom

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

Moorfields Eye Hospital

London
EC1V 2PD
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding

No information available

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

05/02/2018: No publications found, verifying study status with principal investigator.