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ISRCTN
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ISRCTN81872640
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DOI
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10.1186/ISRCTN81872640
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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A trial of intraoperative 5-fluorouracil (5-FU) in primary glaucoma surgery: effects on long term intraocular pressure control and disease progression
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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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G9330070
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Study hypothesis
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The aim of this study is to determine in a prospective, randomised, double masked study if a single intraoperative exposure to 5-FU during glaucoma filtration surgery versus a placebo treatment results in statistically and clinically significant long term differences at various time intervals in the following parameters:
1. Visual function as measured with computerised visual fields testing with multiple point regression analysis
2. Optic disc cupping measured with conventional photographic imaging and three dimensional analysis using the Laser Scanner Ophthalmoscope
3. Intraocular pressure defined as the percentage of patients in each group who have pressure under 21, 17 and 15 off medication
4. Incidence of short and long term surgical complications.
A second purpose of this study is to research in detail the normal long term surgical outcome, complication rate, visual function and optic disc change following glaucoma filtration surgery, particularly the relationship with the level of intraocular pressure
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Lay summary
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Not provided at time of registration
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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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Glaucoma
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Participants - inclusion criteria
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Patients who are deemed to have inadequate intraocular pressure control in one or both eyes with or without medical treatment, who are listed for glaucoma filtration surgery by their consultant
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Participants - exclusion criteria
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1. Anterior segment percutaneous versus aphakia
2. Previous glaucoma filtration surgery
3. Uveitis
4. Any previous intraocular surgery
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Anticipated start date
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01/09/1995
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Anticipated end date
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20/11/2003
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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367
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Interventions
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5-FU versus placebo
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Primary outcome measure(s)
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Levels of intraocular pressure following surgery.
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Secondary outcome measure(s)
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Changes in visual fields and optic disc cupping.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Professor
PT
Khaw
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Address
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Moorfields Eye Hospital and Institute of Ophthalmology
Bath Street
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City/town
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London
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Zip/Postcode
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EC1V 9EL
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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24/10/2000
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Last edited
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06/06/2012
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Date ISRCTN assigned
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24/10/2000
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