Appendix 6Changes to protocol
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| Version number | Revision date | Summary of changes |
|---|
| 1 | 16 September 2020 | Approval of V1 |
| 2 | 27 November 2020 | Inclusion of details for prompting participants to complete eye measurement, and, inclusion of PPI activity as requested by funder for Protocol upload |
| 3 | 16 December 2020 | Edit to state ethic approval had been confirmed rather than submitted and include associated REC reference number |
| 4 | 10 May 2021 | Following discovery that the MRF
VF app was not CE marked and cannot be CE marked in sufficient time to avoid a significant delay to the study, we changed the app we used for monitoring participants engagement with the visual testing aspect of home monitoring for glaucoma. We used the OKKO Visual Health App (OKKO Health) which was CE marked |
| 5 | 1 June 2021 | Edit to add that clinical measures for IOP and visual function may be obtained from medical records if taken within 3 months of baseline assessment |
| 6 | 30 July 2021 | Approval for use of Android tablets instead of iPads which are also compatible with the OKKO Health app. Allows use of alternative technology which may be quicker to resource. Also proposed reducing the home monitoring period from 4 months to 3 months. E-mail/text reminders content also submitted for REC approval |
| 7 | 28 October 2021 | Addition of collecting demographic data on qualitative interview participants. Addition of an e-mail verification which was sent to verify patient participants e-mail address for weekly electronic reminders while undergoing home monitoring. Collection of time of the follow-up appointment on baseline CRF |
| 8 | 16 December 2021 | Amendment to Appendix 1, SSC Charter, to remove KO and add PM from member list |
| 9 | 27 May 2022 | Updated Study Flow Diagram (Appendix 3) plan in accordance with 4 month NIHR funded extension |
| 10 | 27 May 2022 | Update our patient participant PIL to advise patients that they will see their measurements while they are home monitoring – no change to protocol |
PPI, patient and public involvement.
