A trial of intraoperative 5-fluorouracil (5-FU) in primary glaucoma surgery: effects on long term intraocular pressure control and disease progression

ISRCTN	ISRCTN81872640
DOI	https://doi.org/10.1186/ISRCTN81872640
Secondary identifying numbers	G9330070

Submission date: 24/10/2000
Registration date: 24/10/2000
Last edited: 12/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr PT Khaw
Scientific

Moorfields Eye Hospital and Institute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom

Phone	+44 (0)20 7608 6887
Email	p.khaw@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A trial of intraoperative 5-fluorouracil (5-FU) in primary glaucoma surgery: effects on long term intraocular pressure control and disease progression
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Glaucoma
Intervention	5-FU versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	5-fluorouracil
Primary outcome measure	Levels of intraocular pressure following surgery
Secondary outcome measures	Changes in visual fields and optic disc cupping
Overall study start date	01/09/1995
Completion date	20/11/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	367
Key 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
Key exclusion criteria	1. Anterior segment percutaneous versus aphakia 2. Previous glaucoma filtration surgery 3. Uveitis 4. Any previous intraocular surgery
Date of first enrolment	01/09/1995
Date of final enrolment	20/11/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Moorfields Eye Hospital and Institute of Ophthalmology

London
EC1V 9EL
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

12/02/2018: No publications found, verifying study status with principal investigator.