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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePerioperative intravitreal triamcinolone in phacoemulsification for concurrent clinically significant diabetic macular oedema
Study objectivesDoes 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) studiedEye Diseases: Diabetic macular oedema
InterventionTriamcinolone vs no triamcinolone
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)triamcinolone
Primary outcome measureMacular oedema at 1 year
Secondary outcome measures1. Visual acuity at 1 year
2. Macular thickness/volume
3. Retinopathy progression
4. Capsular opacification
5. Macular ischaemia
Overall study start date28/02/2007
Completion date31/08/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants56 (28 patients; 28 controls)
Key inclusion criteria1. 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 criteria1. 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 enrolment28/02/2007
Date of final enrolment31/08/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Moorfields Eye Hospital
London
EC1V 2PD
United Kingdom

Sponsor information

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

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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