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A Randomized Controlled Trial of Low-Cost Model Eyes for Cataract

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A Randomized Controlled Trial of Low-Cost Model Eyes for Cataract A Randomized Controlled Trial of Low-Cost Model Eyes for Cataract Surgical Training of Rural Chinese Ophthalmologists: The China OLIMPICS (Ophthalmic Learning & Improvement Initiative in Cataract Surgery) Trial STUDY PROTOCOL Principal Investigator (Beijing Tongren) – Prof Wang Ningli1 Principal Investigator (Orbis, QUB) – Prof Nathan Congdon MD MPH2, 3, 4 Principal Investigator (LSHTM) – Dr William H Dean FRCOphth MEd MBChB BSc5, 6 Co-Investigators Christopher Magoon3 Dr Peter Xu3 Dr Wen Qing2 Dr Tang Jianjun2 Prof Ciarin O’Neill2 Prof Mathew Burton3 Kang Mengtian1 Huang Wenyong4 Prof Mike Clarke2 Catherine Jan1 1 Beijing Tongren Hospital, People’s Republic of China 2 Queen’s University, Belfast, UK 3 Orbis International, NY, USA 4 Zhongshan Ophthalmic Centre, Guangzhou, China 5 London School of Hygiene & Tropical Medicine, UK 6 University of Cape Town, South Africa This protocol describes the China OLIMPICS Trial, and provides information about procedures for selecting participants and the training involved. The protocol should not be used as a replacement curriculum for current surgical training. Questions relating to this educational-intervention study should be referred, in the first instance, to the primary investigators: Profs Wang Ningli, Nathan Congdon, Matthew Burton and Dr Will Dean This trial will adhere to the principles outlined in the guidelines and protocol of the International Conference on Harmonisation Good Clinical Practice (ICH GCP) and all applicable local and training programme regulations. China OLIMPICS Trial – Study Protocol Version 6.0 28 February 2018 2 Glossary of Abbreviations ...................................................................................................................... 5 Keywords ................................................................................................................................................ 5 General Information ............................................................................................................................... 6 Project Title ............................................................................................................................................. 6 Identifying numbers ................................................................................................................................ 6 Principle Investigator .............................................................................................................................. 6 Coordinating Research Institution .......................................................................................................... 6 Collaborating Training Institutions ......................................................................................................... 6 Study Sponsor ......................................................................................................................................... 7 Study Funders ......................................................................................................................................... 7 Executive Summary ................................................................................................................................ 8 Background Literature Review............................................................................................................... 9 Cataract Surgery ...................................................................................................................................... 9 Surgical Education and Simulation ........................................................................................................ 10 Rationale ............................................................................................................................................... 11 Project aims .......................................................................................................................................... 11 Objectives ............................................................................................................................................. 11 Methodology ........................................................................................................................................ 12 Study Design ......................................................................................................................................... 12 Study Population ................................................................................................................................... 12 Partners: ................................................................................................................................................ 12 Sample Size Calculations ....................................................................................................................... 12 Surgeon Inclusion Criteria ..................................................................................................................... 12 Surgeon Exclusion Criteria .................................................................................................................... 12 Patient Enrolment Criteria .................................................................................................................... 12 Patient Exclusion Criteria ...................................................................................................................... 12 Intervention .......................................................................................................................................... 13 Control .................................................................................................................................................. 13 Outcomes .............................................................................................................................................. 13 Main outcome ................................................................................................................................... 13 Secondary outcomes ......................................................................................................................... 13 Informed Consent ................................................................................................................................. 13 Participant Withdrawal ......................................................................................................................... 14 Randomisation ...................................................................................................................................... 14 Pre-randomisation baseline assessment .......................................................................................... 14 Randomisation Practicalities ............................................................................................................ 14 Baseline data ......................................................................................................................................... 14 The Intervention ................................................................................................................................... 15 Follow-up .............................................................................................................................................. 15 Analyses ................................................................................................................................................ 15 Statistical Analysis ............................................................................................................................ 15 Cost Analysis ..................................................................................................................................... 16 Prevention of Bias ................................................................................................................................. 16 Risks and Benefits of the Study ............................................................................................................. 16 Risks .................................................................................................................................................. 16 Benefits ............................................................................................................................................. 17 Benefits to the study participants ............................................................................................................... 17 General benefits .......................................................................................................................................... 17 China OLIMPICS Trial – Study Protocol Version 6.0 28 February 2018 3 Training Timetable ................................................................................................................................ 17 Project Management ............................................................................................................................ 18 Study Management ............................................................................................................................... 18 Trial Steering Committee ...................................................................................................................... 18 Department resources, collaborators & contractual arrangements ..................................................
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