Condition category
Eye Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Roger Wong

ORCID ID

Contact details

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

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 below to request a patient information sheet

Condition

Eye Diseases: Diabetic macular oedema

Intervention

Triamcinolone vs no triamcinolone

Intervention type

Drug

Phase

Not Specified

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes