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.: PACTR201811612918579 Date of Approval: 28/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Red Reflex Study: East Africa
Official scientific title Red Reflex Screening: a comparison of two screening methods for detecting treatable blindness in children
Brief summary describing the background and objectives of the trial Late presentation is a key barrier to good outcomes for congenital cataract and retinoblastoma (Rb) in sub-Saharan Africa, leading to needless blindness for cataract, and death for retinoblastoma. For instance Rb survival in Kenya has been estimated at 23% compared to 97% in developed countries. For cataract, average lag time before operation is measured in years in Africa whereas babies are operated before 8 weeks of age in developed countries. This is the reason why cataract has become the leading cause of childhood blindness in Africa. Increased public understanding of these problems and appropriate screening strategies are two important methods for addressing this problem. Primary health workers have a good opportunity to screen for these conditions; 90% of children are seen by them during their first year of life as part of successful immunization programmes. They are not currently trained / equipped to do red reflex screening which would diagnose cataract and Rb. New technologies are making red reflex screening simpler and more reliable for the non-specialist. We therefore have a well-described public health problem and an opportunity with new technology to address it. Study Objective: To measure and compare 2 devices for nurse led red reflex screening in terms of case detection rates and PPV regarding numbers of children referred with serious treatable eye conditions, specifically cataract and retinoblastoma. SECURE: Saving Eyes and Children Using Red reflex Examination
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SECURE
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 02/12/2018
Actual trial start date 25/11/2018
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 96000
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Arclight One examination using the Arclight device One time examination only Arclight is a solar powered simplified direct ophthalmoscope designed to be easy to use for the non specialist. 48000
Control Group Neocam One time only examination One time only examination Neocam is a newly developed device utilizing infra-red light as well as visible. This has the benefit of not constricting the pupil and therefore increased sensitivity. 48000 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All children presenting under 5 years whose carers consent. Lack of consent Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Day(s) 5 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 06/04/2018 LSHTM
Ethics Committee Address
Street address City Postal code Country
Keppel Street ,Bloomsbury London, Postal code: WC1E 7HT 0000 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Case detection rate At the end of the feasibility pilot and at the end of the trial
Secondary Outcome Positive Predictive Value At the end of the feasibility pilot and at the end of the trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lions Sight First Eye Unit PO Box E180 Blantyre Malawi
Mbarara Hospital Kabale Road Mbarara Uganda
Mbeya Referral Hospital Sisimba Street, Uzunguni, P.O. Box 419 Mbeya. United Republic of Tanzania
Kampala Hospital 6C Makindu Close, Kololo, Kampala Central Division, Central Region Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Seeing is Believing Innovation Fund Grant 4-108, 8 Devonshire Square London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Richard Bowman Keppel Street London United Kingdom Individual
COLLABORATORS
Name Street address City Postal code Country
Bernadetha Shilio Ministry of Helath, University of Dodoma, Building No 11 Dodoma 40478 United Republic of Tanzania
Barnabas Mshangila Mbeya Hospital Mbeya United Republic of Tanzania
G Msuka Queen Elisabeth Central Hospital, PO Box 95 Blantyre Malawi
S Mdala Queen Elizabeth Central Hospital Blantyre Malawi
C S Manda Universtiy of Malawi Blantyre Malawi
John Onyango Mbarara Hospital Mbarara Uganda
G Ssali Mulago Hospital Kampala Uganda
Covadonga Bascaran LSHTM London United Kingdom
Marcia Zondervan LSHTM London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Bowman richard.bowman@lshtm.ac.uk +442079588345 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Associate Professor LSHTM
Role Name Email Phone Street address
Public Enquiries Marcia Zondervan marcia.zondervan@lshtm.ac.uk 00442079588345 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Senior Lecturer LSHTM
Role Name Email Phone Street address
Scientific Enquiries Covadonga Bascaran covadonga.bascaran@lshtm.ac.uk 00442079588345 Keppel Street
City Postal code Country Position/Affiliation
London United Kingdom Research Fellow ICEH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information