The use of ß radiation as an adjunct to trabeculectomy in glaucoma

ISRCTN ISRCTN71955482
DOI https://doi.org/10.1186/ISRCTN71955482
Secondary identifying numbers LORS LT68X
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
03/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr RML Doran
Scientific

Leeds General Infirmary
Eye Department
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 0113 292 2531

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEye diseases
InterventionIt 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 typeOther
Primary outcome measureSuccess 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 measuresNot provided at time of registration
Overall study start date04/01/1993
Completion date31/03/1996

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaPatients undergoing trabeculectomy
Key exclusion criteria'High-risk' glaucoma including juvenile glaucoma
Date of first enrolment04/01/1993
Date of final enrolment31/03/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2002 Yes No