Condition category
Eye Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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 RML Doran

ORCID ID

Contact details

Leeds General Infirmary
Eye Department
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 0113 292 2531

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LORS LT68X

Study information

Scientific title

Acronym

Study hypothesis

To improve the results of trabeculectomy in patients with glaucoma. About 20% of treatments fail because of the development of scar tissue over the fistula.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Eye diseases

Intervention

It is proposed to use 750-1000 cGY of beta radiation to the eye following surgery. Patients will be randomised to receive an active or a dummy plaque and clinically followed up with measurements of intra ocular pressure. (10P).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Success defined as reduction in from baseline at peak drug effect, response rate and quality of life as measured using the Glaucoma disability index. I0P <21 mm Hg.
1. Completed = without medication
2. Qualified = with additional medication

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/01/1993

Overall trial end date

31/03/1996

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing trabeculectomy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

'High-risk' glaucoma including juvenile glaucoma

Recruitment start date

04/01/1993

Recruitment end date

31/03/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11825813

Publication citations

  1. Results

    Rehman SU, Amoaku WM, Doran RM, Menage MJ, Morrell AJ, Randomized controlled clinical trial of beta irradiation as an adjunct to trabeculectomy in open-angle glaucoma., Ophthalmology, 2002, 109, 2, 302-306.

Additional files

Editorial Notes