Tiers Lieu: Visual impairment
Supported by : Streetlab
Consortium: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (CHNO), VYV3 (Groupe VYV), Hôpital Fondation Adolphe de Rothschild (HFAR), Association Valentin Haüy (AVH), Forum des Living Labs en Santé et en Autonomie (LLSA)
Déficiences Visuelles is a nationwide project that aims to offer a range of complementary services, to experiment in real life and accelerate the market launch of innovative digital solutions for visually impaired people, caregivers and healthcare professionals.
The Tiers Lieu service offering
The TL Déficiences visuelles offers a wide range of complementary services for digital health companies:
- Methodological support for experimentation projects:
- Project analysis: CML France methodology Study design, drafting of protocols and appendices: consent, information note;
- Methodological consulting drug/medical device: realization of robust statistical analysis plans, score for test development;
- Feasibility assessment (active file) and/or finding other participating centers;
- Defining the need with doctors and with patients (focus group and user-led workshops);
- Panel and participant recruitment: Cohort recruitment, testing, site identification, trial deployment, mobilization of expertise;
- Training workshops for expert users of solutions/healthcare professionals, raising awareness;
- Evaluation of prototype, clinical trial.
- Technical and regulatory support :
- Study assessment, definition of legal and regulatory obligations to be met;
- Expertise CPP/RGPC/CNIL, preparation of documents, (example: submission document to the Comité de Protection des Personnes), expertise on European and American regulations;
- Accompaniment towards reimbursement authorizationby social security (article 51);
- Accompaniment on regulatory aspects, CE marking, market access strategies.
- Identification of complementary funding opportunities for projects and assistance in setting up in response to calls for projects (e.g. Bpifrance, Region, Europe, private investment funds) and project management when TL is involved
- Certification of technologies developed (label)
Tiers Lieu projects
Project 1: VISIONUM
Supplier: STREETLAB
Need : Currently, the benefits of orthoptic rehabilitation in low vision are recognized and subjectively quantifiable, but few tools quantify the results of visual tests objectively. Experience in the field shows that, at present, paper-based exercises are offered to patients between office sessions with the orthoptist, in order to improve the visual strategies they have learned, but very few of these are carried out at home, and in the long term, many patients stop doing them altogether. What's more, the number of orthoptists available to care for these low-vision patients is still too low to meet the need. What's more, there is a wide disparity in the distribution of orthoptists across the country.
.Solution : Visionum aims to enable low-vision orthoptists to offer their patients undergoing rehabilitation a fun, innovative digital tool offering personalized rehabilitation exercises that complement in-office sessions, at home for training, and in hospital.
Apport du Tiers Lieu : Measuring the usability/acceptability, effectiveness and medico-economic impact of the personalized, remote orthoptic self-education program.
Project 2: OdySight
Supplier: Tilak Healthcare
Need: In France, access to ophthalmological care is sometimes difficult: lack of healthcare professionals, growing increase in complex age-related visual pathologies (AMD...) requiring enhanced monitoring. The development of new remote self-monitoring tools is therefore a key factor in improving the population's visual health. OdySight, thus enables optimized and personalized patient monitoring, while maintaining a permanent link with the doctor (alerts and appointment scheduling).
Solution : OdySight is a medical device (mobile application) designed for remote monitoring of visual parameters in patients requiring regular follow-up.
Third-Party Contribution: As this is a digital solution aimed mainly at the elderly, we need to demonstrate to ophthalmologists that this population is eligible for our solution with high adoption and accessibility rates in order to improve its prescription. Our experimentation at the Tiers Lieu will enable us to strengthen our pre-marketing file.