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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11825813
Publication citations
-
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.