Condition category
Eye Diseases
Date applied
24/10/2000
Date assigned
24/10/2000
Last edited
17/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes

17/11/2015: No publications found on PubMed.