Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201508001235339 Date of Approval: 12/08/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized Controlled Trial Comparing Selective Laser Trabeculoplasty and Timolol for Treatment of Glaucoma in Tanzania
Official scientific title A Randomized Controlled Trial Comparing Selective Laser Trabeculoplasty and Timolol for Treatment of Glaucoma in Tanzania
Brief summary describing the background and objectives of the trial Glaucoma is the leading cause of irreversible blindness in Sub-Saharan Africa (SSA) including Tanzania. The objective of the trial is to evaluate whether SLT is superior to topical Timolol for the treatment of glaucoma in terms of IOP reduction, acceptance and cost-analysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KiGIP
Disease(s) or condition(s) being studied Eye Diseases,Glaucoma
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 17/08/2015
Actual trial start date 24/08/2015
Anticipated date of last follow up 16/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
NIMR/HQ/R.8a/Vol. IX/1929 National Institute for Medical Research
LSHTM Ethics Reference 7166 Observational/Interventions Research Ethics Committee, London School of Hygiene & Tropical Medicine
Research Ethical Clearance Certificate No. 800 College Research Ethics Review Committee, Kilimanjaro Christian Medical University College
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation with a block size between 4 and 8 (varying at random) Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Selective Laser Trabeculoplasty Single treatment may be repeated once if success criteria are not met on follow-up Intervention of around 5min The short laser intervention facilitates an improved outflow of aqueous out of the eye 180
Control Group Timolol eye drops Twice daily As long as success criteria are met Topical application of drops into the eye which reduce the production of aqueous 180 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
IOP above 21mmHg in the study eye Open chamber angle with sufficient visualisation of angle structures (Shaffer II or more) on Gonioscopy Clear media (cornea, anterior chamber) to visualise the chamber angle Glaucomatous optic disc changes (structural changes due to glaucoma) with or without glaucomatous visual field defects (functional changes due to glaucoma) or high risk chronic open-angle glaucoma suspect. Ability to provide informed consent Willingness to return for regular follow-up visits Pseudophakic patients will be enrolled if the chamber angle is open and the anterior segment shows no signs of inflammation. No perception of light History of previous glaucoma surgery including other laser treatment History of previous uveitis Neovascular glaucoma Physical inability to administer topical treatment Age below 18 years. Pregnant women History of asthma, bradycardia, previous heart failure, hypersensitivity to beta-blockers or systemic use of beta-blockers. 18 Year(s) 110 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/01/2015 College Research Ethics Review Committee, Kilimanjaro Christian Medical University College
Ethics Committee Address
Street address City Postal code Country
Sokoine Road Moshi - United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/10/2014 Observational / Interventions Research Ethics Committee, London School of Hygiene & Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/03/2015 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Success defined as intraocular pressure below or equal to target pressure Intraoculare pressure is measured at baseline, 2months, 6 months, 9 months and 12months.
Secondary Outcome Success rates with fixed thresholds and mean intraocular pressure Intraoculare pressure is measured at baseline, 2months, 6 months, 9 months and 12months.
Secondary Outcome Visual acuity and visual field Visual acuity is measured at baseline, 2months, 6 months, 9 months and 12months. Visual field is tested at baseline and 12months.
Secondary Outcome Complication rates Complications are monitored and registered at 2months, 6 months, 9 months and 12months after the baseline visit.
Secondary Outcome Quality of life and other patient reported outcomes Baseline, 2 months, 6 months, 9 months and 12months.
Secondary Outcome Cost analysis Baseline, 2months, 6 months, 9 months and 12months.
Secondary Outcome Qualitative analysis Interviews and discussions between 9 and 12 months after baseline.
Secondary Outcome Structural changes of the optic disc, cornea or other affected structures Baseline, 2 months, 6 months, 9 months and 12 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eye Department Kilimanjaro Christian Medical Centre Sokoine Road Moshi - Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Seeing is Believing / Standard Chartered Bank 1 Basinghall Avenue London EC2V 5DD United Kingdom
CBM Stubenwald-Allee 5 Bensheim 64625 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Eye Department, Kilimanjaro Christian Medical Centre Sokoine Road Moshi - United Republic of Tanzania
London School of Hygiene & Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Matthew Burton Matthew.Burton@lshtm.ac.uk +44 (0) 20 76368636 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Reader
Role Name Email Phone Street address
Public Enquiries Heiko Philippin philippin@gmx.de +255 (0) 272754890 Sokoine Road
City Postal code Country Position/Affiliation
Moshi - United Republic of Tanzania Glaucoma Consultant
Role Name Email Phone Street address
Scientific Enquiries Heiko Philippin philippin@gmx.de +255 (0) 272754890 Sokoine Road
City Postal code Country Position/Affiliation
Moshi - United Republic of Tanzania Glaucoma Consultant
REPORTING
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Result URL Hyperlinks
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