What is the best anti-scarring treatment for combined cataract and drainage surgery in routine operations for combined glaucoma and cataract in Tanzania?
| ISRCTN | ISRCTN36436933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36436933 |
| Protocol serial number | N/A |
| Sponsor | University College London (UCL) (UK) |
| Funders | Fight for Sight (UK) (ref: DFFM/UCL), International Glaucoma Association (UK) (ref: DEHC/UCL) |
- Submission date
- 24/09/2009
- Registration date
- 30/11/2009
- Last edited
- 09/09/2016
- 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 Ian Murdoch
Scientific
Scientific
Epidemiology and International Eye Health
Department of Genetics
Insititute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom
| i.murdoch@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Is beta-radiation better than 5-fluorouracil as an adjunct for trabeculectomy when combined with cataract surgery? A single centre randomised controlled trial |
| Study objectives | Beta radiation offers improved pressure control with a retained safety profile when used as an adjunct in combined trabeculectomy and cataract surgery. |
| Ethics approval(s) | National Institute for Medical Research and Ministry of Health and Social Welfare, Dar es Salaam (Tanzania) provided clearance certificates for conducting Medical Research in Tanzania, 25/07/2008 and 13/08/2008, ref: NIMR/HQ/R.8a/Vol.IX/717 and NIMR/HQ/R.8a/Vol.IX/723 |
| Health condition(s) or problem(s) studied | Open angle glaucoma |
| Intervention | Patients are randomised to either 5-fluorouracil or beta-radiation as follows: 1. 5-fluorouracil is applied subconjunctivally for a period of 3 minutes at a concentration of 50 mg/ml prior to undertaking the drainage flap 2. Beta-radiation is applied with a Strontium-90 containing delivery device to the closed conjuntival surface at the conclusion of surgery. Using the decay chart for the probe the correct time interval is used to deliver 1000 cGy of Beta irradiation (approximately 8 minutes). The main outcome is at one year post-operatively. |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Beta-radiation, 5-fluorouracil |
| Primary outcome measure(s) |
Intraocular pressure at 12 months post-operatively. Surgical success at twelve months is defined as a maximum intraocular pressure less than 16 mmHg as measured using Goldmann tonometry on no ocular hypotensive therapy. |
| Key secondary outcome measure(s) |
1. Visual function, assessed within or at the first year after surgery |
| Completion date | 01/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 298 |
| Key inclusion criteria | 1. Consent to inclusion and participation in trial 2. Characteristic glaucomatous changes in the optic disc. 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. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.8. 3. 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 4. An open angle on gonioscopy 5. Visually significant cataract 6. Aged greater than 20 years, either sex |
| Key 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 (last menstrual period [LMP]) 12. No clinically significant cataract 13. Chronic use of topical or systemic steroids |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
- Tanzania
Study participating centre
Insititute of Ophthalmology
London
EC1V 9EL
United Kingdom
EC1V 9EL
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 | 08/09/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/09/2016: Publication reference added.
