Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0141187727
Study information
Scientific title
Perioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema
Acronym
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Eye Diseases: Diabetic macular oedema
Intervention
Triamcinolone vs no triamcinolone
Intervention type
Drug
Phase
Not Applicable
Drug names
triamcinolone
Primary outcome measures
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 trial start date
28/02/2007
Overall trial end date
31/08/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
56 (28 patients; 28 controls)
Participant 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
Recruitment start date
28/02/2007
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Moorfields Eye Hospital NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary