Contact information
Type
Scientific
Primary contact
Dr PT Khaw
ORCID ID
Contact details
Moorfields Eye Hospital and Institute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom
+44 20 7608 6887
p.khaw@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9330070
Study information
Scientific title
A trial of intraoperative 5-fluorouracil (5-FU) in primary glaucoma surgery: effects on long term intraocular pressure control and disease progression
Acronym
Study hypothesis
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
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
Glaucoma
Intervention
5-FU versus placebo
Intervention type
Drug
Phase
Not Specified
Drug names
5-fluorouracil
Primary outcome measures
Levels of intraocular pressure following surgery.
Secondary outcome measures
Changes in visual fields and optic disc cupping.
Overall trial start date
01/09/1995
Overall trial end date
20/11/2003
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
367
Participant exclusion criteria
1. Anterior segment percutaneous versus aphakia
2. Previous glaucoma filtration surgery
3. Uveitis
4. Any previous intraocular surgery
Recruitment start date
01/09/1995
Recruitment end date
20/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Moorfields Eye Hospital and Institute of Ophthalmology
London
EC1V 9EL
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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