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ISRCTN
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ISRCTN71955482
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ClinicalTrials.gov identifier
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Public title
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The use of ß radiation as an adjunct to trabeculectomy in glaucoma
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Scientific title
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Acronym
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N/A
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Serial number at source
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LORS LT68X
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Study hypothesis
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To improve the results of trabeculectomy in patients with glaucoma. About 20% of treatments fail because of the development of scar tissue over the fistula.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Eye diseases
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Participants - inclusion criteria
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Patients undergoing trabeculectomy
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Participants - exclusion criteria
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'High-risk' glaucoma including juvenile glaucoma
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Anticipated start date
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04/01/1993
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Anticipated end date
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31/03/1996
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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It is proposed to use 750-1000 cGY of beta radiation to the eye following surgery. Patients will be randomised to receive an active or a dummy plaque and clinically followed up with measurements of intra ocular pressure. (10P).
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Primary outcome measure(s)
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Success defined as reduction in from baseline at peak drug effect, response rate and quality of life as measured using the Glaucoma disability index. I0P <21 mm Hg.
1. Completed = without medication
2. Qualified = with additional medication
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11825813
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Contact name
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Mr
RML
Doran
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Address
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Leeds General Infirmary
Eye Department
Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Tel
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+44 0113 292 2531
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Email
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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03/12/2008
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Date ISRCTN assigned
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23/01/2004
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