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
Protocol serial number	G9330070
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	5-fluorouracil
Primary outcome measure(s)	Levels of intraocular pressure following surgery
Key secondary outcome measure(s)	Changes in visual fields and optic disc cupping
Completion date	20/11/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Moorfields Eye Hospital and Institute of Ophthalmology

London
EC1V 9EL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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