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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN90614292 |
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Date of registration:
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30/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised Controlled Trial of Intravitreal Triamcinolone in Patients with Diabetic Macular Oedema Refractory to Laser Treatment
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Scientific title:
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Date of first enrolment:
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28/11/2003 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN90614292 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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S A
Vernon |
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Address:
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B Floor
The Eye & ENT Unit
University Hospital
NG7 2UH
Nottingham
United Kingdom |
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Telephone:
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+44 (0)115 924 9924 |
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Email:
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stephen.vernon@nuh.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Not provided at time of registration
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Eye Diseases: Diabetic macular oedema
Eye Diseases
Diabetic macular oedema
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Intervention(s)
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1. Intravitreal injection of tiamcinolone
2. Placebo
As of March 2008: trial abandoned due to poor recruitment.
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Primary Outcome(s)
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Pre-injection and then month 1, 3 and 6
1. Best corrected visual acuity (logarithm of the minimum angle of resolution [logMAR]) at each visit. A change in either direction of 10 letters on the logMAR chart would be considered significant
2. Near vision tested with a standard add on each visit, with time taken to read the standard N paragraph and the number of mistakes made
3. Intra-ocular pressure at each visit - measured by standard applanation tonometry
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0192133909
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Source(s) of Monetary Support
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Queen's Medical Centre University Hospital NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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