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Authors
Veldman, Manon H. J.
van der Aa, Hilde P. A.
Bode, Christina
Knoop, Hans
Hulshof, Carel T. J.
Koopmanschap, Marc
Stavleu, Edwin
van Rens, Ger H. M. B.
van Nispen, Ruth M. A.
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Funding
Funding for this research was provided by:
ZonMw (94313003)
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Article History
Received: 30 June 2021
Accepted: 10 December 2021
First Online: 28 December 2021
Declarations
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: This study protocol has been reviewed and approved by the Medical Ethical Committee of the VU University Medical Centre Amsterdam, the Netherlands (reference no. 2019/027, NL67802.029.18). Important protocol modifications have to be accredited by the Medical Ethical Committee and will be communicated to relevant parties. The trial will be conducted according to the principles of the Declaration of Helsinki (seventh revision 2013), the Medical Research Involving Human Subjects Act (WMO) and the EU General Data Protection Regulation (GDPR). Recruitment of E-nergEYEze starts in August 2020 and is expected to end in April 2022. Final assessments are expected to be done in April 2023. All participants will sign an informed consent form to participate in the trial at home and will be screened for eligibility by a researcher of the Low Vision Research group. After the baseline assessment is done, randomization will take place and on the consent form, participants will be asked to agree to collect and use their data for data analysis and future research on visual impairment and fatigue complaints. If participants choose to withdraw from the trial their data will be used, unless otherwise requested. The trial does not involve collecting biological specimens for storage. The sponsor’s insurance policy provides coverage for damage to research subjects through injury or death caused by participation in the study. The study has been registered in the Dutch Trial Register (reference number NTR7764). Moreover, the study has been assessed by the science committee of the Amsterdam Public Health research institute. The trial will be conducted and reported following the SPIRIT (Standard Protocol Items Recommendations for Interventional Trials) statement. All named authors adhere to the authorship guidelines of Trials. All authors have agreed to publication. Results will be published in peer-reviewed journals and presented at both national and international conferences.
: Not applicable
: The authors declare that they have no competing interests.
