An international consortium of over 80 of the world’s experts in low vision (LV) and ultra low-vision (ULV) in the field of vision restoration has presented several key recommendations on the measurement and reporting of patient outcomes in vision restoration trials. The International Harmonization of Outcomes and Vision Endpoints in Vision Restoration Trials (HOVER) Taskforce looked at seven topic areas to formulate guidelines for performing and reporting psychophysical tests in humans who participate in clinical trials for visual restoration. The report of the research was published in ARVO’s Translational Vision Science & Technology (Trans Vis Sci Tech. 2020;9(8):25,). Importantly, the report supports the comparison of different outcomes between different groups in vision research groups aligning results, tests and reporting guidelines to facilitate systematic and meta-analyses on a global stage. The Taskforce have additionally supported other research groups or companies that choose to follow these guidelines and include a specific statement to that effect in their communications to the public.
Several broad topics included visual acuity, electrophysiology, electrically evoked device effectiveness, vision processing systems, orientation and mobility assessments, patient-reported outcomes, ethical considerations and specialised topics. Each of the topics used a standard structure for a brief introduction and then focused on methodology, specifications, techniques, testing, analysis, recommendations and reporting guidelines. Two of the authors, Lauren Ayton at the University of Melbourne, Australia, and Joseph Rizzo at Massachusetts Eye and Ear Infirmary, Harvard Medical School, commented that “large numbers of research teams and companies around the globe have been pursuing a wide range of approaches to achieve this goal, including genetic, prosthetic, optogenetic, stem cell and other transplantation, and sensory substitution strategies. Each approach has advantages and disadvantages, and no approach will likely prove to be well suited for all forms of neural blindness.” However, a clear consensus is aimed to present a “living document” to be updated on a 2-yearly report to ensure the field progresses in step for the purpose of supporting activities for clinicians and patients alike. A website will be updated periodically to continue worldwide efforts to align the Taskforce’s recommendations.
A number of the topics such as orientation and mobility (OM), or full-field stimulus (FST), and other ULV and LV tests, may have very relevant advice for current clinical studies for patients for LCA or continuously iterations on ophthalmic/bionic implants. The Taskforce have provided reporting guidelines for any publication or presentation to contain sufficient information so that another group can replicate the testing methodology. This will also be relevant for orphan populations where clinical trial cohorts may work on very small size populations and therefore collecting outcomes across different groups will benefit showing more relevant statistical results, especially reporting primary endpoints and a p-value (≤0.05). Finally, the HOVER Taskforce has invited any authors to adhere their guidelines and include a specified statement in their manuscript and this should support clinical, academic and commercial researchers to compare and contrast outcomes across various disciplines.