An open-label, multi-center study exploring TECLens’ innovative medical device targeting presbyopia has been announced on ClinicalTrials.gov. The trial, titled Quantitative Refractive Crosslinking in Presbyopia-Aged Patients, is marked as not yet recruiting as of October 7, 2025. Clinical, regulatory, and quality professionals should monitor this development closely.
What changed?
TECLens, Inc., in collaboration with Robert Ang, MD, and the Asian Eye Institute, has listed an ambitious Phase I clinical trial evaluating the device-driven Quantitative Refractive Crosslinking procedure for presbyopia management. This marks an important step in addressing age-related vision issues. Notably, the study has not yet commenced recruitment, highlighting a pre-initiation stage.
What are the trial details?
Who is leading this study?
The trial is spearheaded by TECLens, Inc., with Dr. Robert Ang serving as principal investigator. His affiliation with both TECLens and the Asian Eye Institute strengthens the effort through multidisciplinary collaboration.
What is the intervention being studied?
The intervention is a device-based procedure termed Quantitative Refractive Crosslinking, focusing on presbyopia patients. According to the trial listing, this device aims to improve refractive characteristics in those affected by age-related changes in near vision.
What type of trial is this?
The study is an open-label, multi-center Phase I trial. Open-label means neither patients nor investigators will be blinded to the treatment protocol. Multi-center involvement underscores efforts for diversified patient inclusion, ensuring results are broadly reliable.
Current recruitment status
As of publication, the recruitment process has not yet begun, potentially signaling preparatory regulatory submissions or finalization of centers for enrollment.
What does this mean for stakeholders?
Clinical teams must prepare for potential metrics surrounding device performance and safety evaluations. Quality professionals should anticipate updates on manufacturing norms as the trial progresses. Regulatory teams can expect information pertinent to premarket evaluation filings, advancing alignment under Medical Device Regulation (MDR) Annex XIV provisions.
Stakeholders evaluating competitive technologies should focus on monitoring this trial’s progress for benchmarks against alternative presbyopia solutions.
FAQs
1. What is presbyopia?
Presbyopia is an age-related condition where the eye’s lens loses flexibility, leading to difficulty focusing on close objects.
2. What is the role of Quantitative Refractive Crosslinking in presbyopia management?
This device-based approach aims at improving refractive ability, potentially restoring near vision function in presbyopia patients.
3. Who is the manufacturer of the device being studied?
The device is developed by TECLens, Inc., a company focused on innovative ophthalmic solutions.
Conclusion
TECLens is advancing its device-centric presbyopia study, indicating growing, innovative development within the ophthalmic field. Professionals across clinical, quality, and regulatory spaces should monitor updates for insights into trial success and implications upon approval pathways.
Disclaimer
The information provided in this article is based on publicly available trial data and is intended for informational purposes. It is not legal or regulatory advice.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07208604?term=medical+device