Condition category
Eye Diseases
Date applied
24/09/2009
Date assigned
30/11/2009
Last edited
09/09/2016
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

Mr Ian Murdoch

ORCID ID

Contact details

Epidemiology and International Eye Health
Department of Genetics
Insititute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom
-
i.murdoch@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Is beta-radiation better than 5-fluorouracil as an adjunct for trabeculectomy when combined with cataract surgery? A single centre randomised controlled trial

Acronym

Study hypothesis

Beta radiation offers improved pressure control with a retained safety profile when used as an adjunct in combined trabeculectomy and cataract surgery.

Ethics approval

National Institute for Medical Research and Ministry of Health and Social Welfare, Dar es Salaam (Tanzania) provided clearance certificates for conducting Medical Research in Tanzania, 25/07/2008 and 13/08/2008, ref: NIMR/HQ/R.8a/Vol.IX/717 and NIMR/HQ/R.8a/Vol.IX/723

Study design

Single-centre 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

Open angle glaucoma

Intervention

Patients are randomised to either 5-fluorouracil or beta-radiation as follows:
1. 5-fluorouracil is applied subconjunctivally for a period of 3 minutes at a concentration of 50 mg/ml prior to undertaking the drainage flap
2. Beta-radiation is applied with a Strontium-90 containing delivery device to the closed conjuntival surface at the conclusion of surgery. Using the decay chart for the probe the correct time interval is used to deliver 1000 cGy of Beta irradiation (approximately 8 minutes).
The main outcome is at one year post-operatively.

Intervention type

Drug

Phase

Phase III

Drug names

Beta-radiation, 5-fluorouracil

Primary outcome measures

Intraocular pressure at 12 months post-operatively. Surgical success at twelve months is defined as a maximum intraocular pressure less than 16 mmHg as measured using Goldmann tonometry on no ocular hypotensive therapy.

Secondary outcome measures

1. Visual function, assessed within or at the first year after surgery
2. Reintervention, assessed within or at the first year after surgery
3. Reintervention acceptance, assessed within or at the first year after surgery
4. Surgical complications, measured during surgery and within two weeks of surgery

Overall trial start date

01/05/2009

Overall trial end date

01/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consent to inclusion and participation in trial
2. Characteristic glaucomatous changes in the optic disc. The presence of a focal or diffuse area of optic disc rim loss, so that the neuroretinal rim tissue in any quadrant is less than 5% of the disc diameter in that meridian. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.8.
3. A measured intraocular pressure greater than or equal to 21 mmHg on at least one visit before the time of listing for surgery as measured by Goldmann applanation tonometry
4. An open angle on gonioscopy
5. Visually significant cataract
6. Aged greater than 20 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

298

Participant exclusion criteria

1. Unwillingness to participate in the study
2. Anterior segment neovascularisation
3. Past trauma to the eye or ocular adnexae
4. Retinal or optic nerve neovascularisation
5. Aphakia or pseudophakia
6. Previous ocular surgery
7. Uveitis
8. Inability/unwillingness to give informed consent
9. Unwillingness to accept randomisation
10. Patient less than 20 years of age
11. Pregnancy or female of childbearing age who may be pregnant at time of treatment (last menstrual period [LMP])
12. No clinically significant cataract
13. Chronic use of topical or systemic steroids

Recruitment start date

01/05/2009

Recruitment end date

01/05/2014

Locations

Countries of recruitment

Tanzania

Trial participating centre

Insititute of Ophthalmology
London
EC1V 9EL
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Epidemiology and International Eye Health
Department of Genetics
Institute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom
-
i.murdoch@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Fight for Sight (UK) (ref: DFFM/UCL)

Alternative name(s)

FFS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

International Glaucoma Association (UK) (ref: DEHC/UCL)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27606611

Publication citations

Additional files

Editorial Notes

09/09/2016: Publication reference added.