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
Secondary identifying numbers	N/A

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

Epidemiology and International Eye Health
Department of Genetics
Insititute of Ophthalmology
Bath Street
London
EC1V 9EL
United Kingdom

Email	i.murdoch@ucl.ac.uk

Study information

Study design	Single-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Beta-radiation, 5-fluorouracil
Primary outcome measure	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.
Secondary outcome measures	1. Visual function, assessed within or at the first year after surgery 2. Reintervention, assessed within or at the first year after surgery 3. Reintervention acceptance, assessed within or at the first year after surgery 4. Surgical complications, measured during surgery and within two weeks of surgery
Overall study start date	01/05/2009
Completion date	01/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

England
Tanzania
United Kingdom

Study participating centre

Insititute of Ophthalmology

London
EC1V 9EL
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

Epidemiology and International Eye Health
Department of Genetics
Institute of Ophthalmology
Bath Street
London
EC1V 9EL
England
United Kingdom

Email	i.murdoch@ucl.ac.uk
Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Fight for Sight (UK) (ref: DFFM/UCL)
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Fight for Sight, Inc., National Council to Combat Blindness, Fight for Sight (U.S.), FFS
Location: United States of America

International Glaucoma Association (UK) (ref: DEHC/UCL)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

09/09/2016: Publication reference added.