The use of ß radiation as an adjunct to trabeculectomy in glaucoma
| ISRCTN | ISRCTN71955482 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71955482 |
| Protocol serial number | LORS LT68X |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
Scientific
Leeds General Infirmary
Eye Department
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 0113 292 2531 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients undergoing trabeculectomy |
| Key exclusion criteria | 'High-risk' glaucoma including juvenile glaucoma |
| Date of first enrolment | 04/01/1993 |
| Date of final enrolment | 31/03/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
