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: www.pactr.org
Trial no.: PACTR201803002159198 Date of Approval: 30/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Simulated Ocular Surgery (SOS) Trials
Official scientific title The Simulated Ocular Surgery (SOS) Trials: Randomised-Controlled Trials Comparing Intense Simulation-Based Surgical Education for Cataract and Glaucoma Surgery to Conventional Training Alone in East Africa.
Brief summary describing the background and objectives of the trial There is a huge need to perform high volumes of surgery in sub-Saharan Africa, to tackle the backlog of avoidable blindness. There is a great need to train many eye surgeons safely, efficiently, effectively, and to an acceptable level of competence. There is also a need to maintain and improve the quality and outcomes of surgery. Currently, surgical training is often conducted using the traditional ¿apprentice model¿, where a trainee observes a qualified surgeon and learns from them, and then the surgeon supervises the trainee performing surgery on a patient. We believe that this conventional model has substantial limitations and drawbacks, making surgical training less efficient and less safe. We will test the hypothesis that intense modular simulation-based ophthalmic surgical education is superior to conventional training for the initial acquisition of competence. Pilot studies have been conducted to develop, test and refine aspects of modular simulation-based ophthalmic surgical training in cataract and glaucoma surgery. Assessment tools have been developed and validated for use in this simulation-based training (see Appendices 3a and 3b). Subsequent to these pilot and validation studies, we are now able to test the efficacy of focussed modular simulation-based ophthalmic surgical training in two separate parallel-group randomised controlled trials. We will conduct two independent trials of intense simulation-based ophthalmic surgical education for training ophthalmologists in the procedures for cataract, and separately for glaucoma: the two leading causes of blindness in sub-Saharan Africa. Trainee eye surgeons will be randomised to the ¿intervention¿ of focussed simulation-based surgical training, or to the ¿control¿ group of current conventional training. Follow-up assessments will measure whether the trainees have gained in surgical competence (objectively assessed using a specific and validated grading score).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SOS
Disease(s) or condition(s) being studied Educational intention, cataract, glaucoma,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/10/2017
Actual trial start date
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
P473/08/2017 Kenyatta National Hospital - University of Nairobi Ethics Research Committee
13/06-17 Mbarara University REC
2027/1070 KCMC RERC
11795 London School of Hygiene & Tropical Medicine
259/2017 UCT HREC (Human research ethics committee)
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 Random number generation, Block randomisation Separate independent statistician Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intense simulation-based surgical training 8 days of training 8 days of training Intense simulation-based surgical training 16 Dose Comparison
Experimental Group Intense simulation-based surgical training 8 days of training 8 days of training Intense simulation-based surgical training 32 Active-Treatment of Control Group
Control Group Conventional Standard Training Alone Standard conventional training 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
OLIMPICS Trial (SICS): Inclusion Criteria ¿ Less than one complete SICS procedure performed ¿ Parts of less than ten separate SICS procedures performed ¿ Trainee ophthalmologist in year one or two of MMed course of collaborating Institution. ¿ Agree to be randomly allocated to ¿Intervention¿ or ¿Control¿ training groups ¿ Agree to, and sign agreement not discuss, or share in any way, any of the details of the educational intervention for the first three months ¿ Agree to baseline assessment, assessment at three, twelve and fifteen months; Agree to monitor, anonymise, and report all surgical outcomes of all patients operated during the fifteen month period (month 0 to 15) ¿ Good English language skills OLIMPICS Trial (SICS): Exclusion Criteria ¿ One or more complete SICS procedures performed ¿ Performed parts of ten or more separate SICS procedures GLASS Trial (Trabeculectomy): Inclusion Criteria ¿ Less than one complete surgical trabeculectomy procedure performed ¿ Parts of less than five surgical trabeculectomy procedures performed ¿ Trainee ophthalmologist in year three or four of MMed course of collaborating Institution ¿ Agree to be randomly allocated to ¿Intervention¿ or ¿Control¿ training groups ¿ Agree, and sign agreement to not discuss, or share in any way, and of the details of the educational intervention for the first three months ¿ Agree to baseline assessment, assessment at three, twelve and fifteen months; Agree to monitor, anonymise, and report all surgical outcomes of all patients operated during the fifteen month period (month 0 to 15) ¿ Good English language skills GLASS Trial (Trabeculectomy): Exclusion Criteria ¿ One or more trabeculectomy procedures performed ¿ Performed parts of five or more separate trabeculectomy procedures 20 Year(s) 50 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 08/05/2017 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 03/05/2017 UCT HREC (Human research ethics committee)
Ethics Committee Address
Street address City Postal code Country
Groote Schoor Hospital, Main Road Cape Town 7925 South Africa
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 12/10/2017 UNCHS/KNH ERC
Ethics Committee Address
Street address City Postal code Country
P O Box 20723 Nairobi 00202 Kenya
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 31/08/2017 Mbarara University REC
Ethics Committee Address
Street address City Postal code Country
P O Box 1410 Mbarara Uganda
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 03/10/2017 Kilimanjaro Christian Medical College REC
Ethics Committee Address
Street address City Postal code Country
P O Box 2240 Moshi Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean global competency assessment score, using the ophthalmic simulation surgical competency assessment rubric (OSSCAR) at three-months post-training intervention.
Secondary Outcome mean global competency assessment score, using the ophthalmic simulation surgical competency assessment rubric (OSSCAR) at twelve-months post-training intervention.
Secondary Outcome mean global competency assessment score, using the ophthalmic simulation surgical competency assessment rubric (OSSCAR) at fifteen-months post-training intervention.
Secondary Outcome mean global competency assessment score, using the ophthalmology surgical competency assessment rubric (OSCAR) at six-months post-training intervention
Secondary Outcome mean global competency assessment score, using the ophthalmology surgical competency assessment rubric (OSCAR) at twelve-months post-training intervention
Secondary Outcome Numbers and visual outcomes of surgeries During one year post-training intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbarara University & Referral Hospital Eye Centre (MURHEC) Mbarara University of Science and Technology, PO BOX 1410 Mbarara Uganda
Kilimanjaro Christian Medical Centre (KCMC) Moshi Tanzania
Department of Ophthalmology, University of Nairobi Kenyatta National Hospital, PO Box 19676 Nairobi 00202 Kenya
Department of Ophthalmology, School of Medicine PO Box 7062, Makerere University Kampala Uganda
Department of Ophthalmology, University of Zimbabwe Churchill Avenue, Mount Pleasant Harare Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
British Council for the Prevention of Blindness 4 Bloomsbury Square London WC1a 2RP United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor LSHTM London School of Hygiene & Tropical Medicine, Keppel Street London WC1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Dr Simon Arunga Mbarara University of Science and Technology Mbarara Uganda
Dr John Buchan London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT United Kingdom
Prof. Matthew Burton London School of Hygiene and Tropical Medicine, Keppel Street London WC1E 7HT United Kingdom
Prof Colin Cook Groote Schuur Hospital, University of Cape Town, Main Road Cape Town 7925 South Africa
Dr Stephen Gichuhi Department of Ophthalmology, Kenyatta Hospital Nairobi 00202 Kenya
Prof Rangarirai Masanganise Departmetn of Ophthalmology, Parirenyatwa Hospital Harare Zimbabwe
Dr William U Makupa Kilimanjaro Christian Medical Centre Moshi Tanzania
Dr Juliet Otiti Ophthalmology Department, Makerere University Hospital Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator William Dean will.dean@lshtm.ac.uk +27710701272 H53 Old Main Building, Groote Schuur Hospital
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Clinical Research Fellow
Role Name Email Phone Street address
Public Enquiries Patricia Henley Patricia.Henley@lshtm.ac.uk +442079272626 London School of Hygiene & Tropical Medicine, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Quality & Governance Manager
Role Name Email Phone Street address
Scientific Enquiries Matthew Burton Matthew.Burton@lshtm.ac.uk +442079588316 London School of Hygiene & Tropical Medicine, Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 07/03/2018 New Information 2017-07-03 2017-10-30
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/03/2018 Modified Not yet recruiting Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 06/03/2018 New information Single group: all participants receive same intervention throughout study Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 07/03/2018 New Information Educational intention Educational intention, cataract, glaucoma
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 07/03/2018 New Information 2017-07-03 2017-10-30
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 07/03/2018 Modified Open to recruitment: actively recruiting participants Open to recruitment: actively recruiting participants
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 07/03/2018 New Information Educational intention, cataract, glaucoma Educational intention, cataract, glaucoma
Section Name Field Name Date Reason Old Value Updated Value
SecondaryID SecondaryID List 06/03/2018 New information SECONDARY_ID SECONDARY_ID
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 04/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 04/07/2018 pactr update Other Eye Diseases, Surgery, Other