The CRYSTALSIGHT “Cohort 1.5” clinical investigation study is actively transforming remote eye care. Conducted in partnership with the Tan Tock Seng Eye Clinic and leveraging AI-based technologies, this study aims to advance home monitoring for maculopathy patients. Clinical, quality, and regulatory teams can now assess its implications for the future use of devices like CRYSTALSIGHT for diabetic retinopathy and macular degeneration.
What changed?
On December 1, 2025, CRYSTALSIGHT reached a significant milestone with its “Cohort 1.5” investigation, conducted under the sponsorship of Tan Tock Seng Hospital and Occutrack Medical Solutions Pte Ltd. This study integrates artificial intelligence-led eye tracking technology to introduce high-accuracy remote monitoring for maculopathy.
It represents a significant advancement in personalizing care for conditions such as age-related macular degeneration (AMD) and diabetic retinopathy. The device tests are in an “active, not recruiting” phase according to official updates.
Understanding CRYSTALSIGHT’s role
What is CRYSTALSIGHT?
CRYSTALSIGHT uses advanced AI technology to perform non-invasive assessments of eye conditions like maculopathy. The device is engineered to enable patients to perform tests from their homes while maintaining clinical accuracy. This innovation aligns with the growing need to address age-related vision impairment cost-efficiently.
What conditions does it address?
The CRYSTALSIGHT tests target several eye conditions:
- Maculopathy
- Age-related macular degeneration (dry and wet forms)
- Diabetic retinopathy
- Other age-related vision disorders linked to retinal degeneration
Who is conducting the study?
Sponsors include Tan Tock Seng Hospital, Occutrack Medical Solutions Pte Ltd, National Healthcare Group in Singapore, and the Agency for Science, Technology and Research. This multi-stakeholder approach demonstrates the strategic alignment of clinical medicine, technology innovation, and healthcare research.
Impact on regulatory medicine and patient care
How does this study advance remote monitoring?
CRYSTALSIGHT focuses on delivering trusted clinical data through home-based AI systems. Its performance presents opportunities for regulatory improvements targeting usability, system reliability, and patient adoption rates.
Why is this relevant to regulatory teams?
The implementation of AI-driven medical devices requires robust compliance with frameworks such as MDR Annex XIV. CRYSTALSIGHT’s iterative development systems align with this by emphasizing intended purpose, clinical utility, and patient safety.
Implications for eye care accessibility?
Remote monitoring devices are critical for reducing healthcare inequity while providing specialized care for aging populations. CRYSTALSIGHT’s advancements could set a new standard for accessible diagnostics in ophthalmology.
FAQ
1. What is the main goal of the CRYSTALSIGHT study?
The study aims to develop non-invasive, AI-enabled eye tracking technology for at-home monitoring of maculopathy and other vision disorders.
2. Who sponsors the study?
Sponsorship comes from Tan Tock Seng Hospital, Occutrack Medical Solutions Pte Ltd, National Healthcare Group, and other partners in Singapore.
3. What makes CRYSTALSIGHT different?
Its device integrates real-time AI diagnostics into home-based testing, prioritizing accessibility and accuracy.
Conclusion
The CRYSTALSIGHT “Cohort 1.5” study highlights innovation in home-based ophthalmic monitoring. Its collaboration-driven development and AI capabilities are paving the way for impactful medical device integration, offering opportunities for regulatory progress and expanding remote care access.
Disclaimer
The content in this article is for informational purposes only and does not constitute regulatory, legal, or clinical advice. Professional evaluation and compliance checks are essential.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07255885?term=medical+device