Condition category
Surgery
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
06/02/2015
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

Mr Ian Murdoch

ORCID ID

Contact details

University College London
Department of Epidemiology & Internal Medicine
11 - 42 Bath Street
London
EC1V 9EL
United Kingdom
+44 (0)20 7608 6896
i.murdoch@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

056045

Study information

Scientific title

The evaluation of adjunctive beta-irradiation for trabeculectomy in South Africa: does it enhance operative success and reduce overall failure in glaucoma management?

Acronym

Study hypothesis

To determine the feasibility of adjunctive beta-irradiation for trabeculectomy in an African setting. To determine the efficacy of adjunctive beta irradiation for trabeculectomy in African glaucoma in South Africa. To establish the pattern of attendance after primary trabeculectomy in an African setting and compliance with subsequent health interventions.

Ethics approval

This study was approved by the research ethics committees of all included centres, along with the Institute of Ophthalmology.

Study design

Randomised prospective double-blind controlled surgical trial of trabeculectomy with either peri-operative Beta irradiation or placebo augmentation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Glaucoma

Intervention

African patients with established primary open angle glaucoma requiring trabeculectomy are recruited in three participating centres in South Africa. Following randomisation, patients undergo primary trabeculectomy with either exposure to 1000 cGy of Beta irradiation at the conclusion of surgery with a Strontium-90 containing delivery device, or a placebo exposure with an apparently identical device. Intraocular pressure is measured at regular intervals for at least 12 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Peri-operative Beta irradiation

Primary outcome measures

Intraocular pressure at 12 months.

Secondary outcome measures

1. Visual assessment
2. Re-intervention rate
3. Surgical complications

Overall trial start date

03/11/1999

Overall trial end date

31/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consent to inclusion and participation in trial
2. Characteristic glaucomatous changes in the optic disc
3. 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
4. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.8
5. 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
6. An open angle on gonioscopy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

320

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 (LMP)
12. Clinically significant cataract
13. Chronic use of topical or systemic steroids

Recruitment start date

03/11/1999

Recruitment end date

19/06/2002

Locations

Countries of recruitment

South Africa

Trial participating centre

University College London
London
EC1V 9EL
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

11 - 42 Bath Street
London
EC1V 9EL
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Charity

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

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

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17023435

Publication citations

  1. Results

    Kirwan JF, Cousens S, Venter L, Cook C, Stulting A, Roux P, Murdoch I, Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial., BMJ, 2006, 333, 7575, 942, doi: 10.1136/bmj.38971.395301.7C.

Additional files

Editorial Notes