TECLens, LLC has partnered with Validcare to support its clinical development efforts focused on presbyopia treatment. The collaboration involves protocol development, electronic source data collection, data management, and statistical analysis services.
The study will evaluate TECLens’ proprietary quantitative corneal cross-linking (qCXL™) technology, which aims to improve reading vision in patients over 40 with presbyopia who rely on reading glasses.
Key Details
Technology Focus: The qCXL™ technology represents an incisionless approach to corneal reshaping that does not involve laser ablation or invasive surgery.
Study Purpose: This proof-of-concept investigation will establish foundational data for expanded clinical development of the refractive cross-linking product.
Validcare’s Role: The CRO will implement a cloud-based, 21 CFR Part 11-compliant platform integrating clinical data, patient feedback, and ocular imaging into a unified database.
Stakeholder Perspectives
Patrick Lopath, TECLens COO, emphasized that “data capture optimization enables rapid refinement of clinical strategy” while maintaining the flexibility needed during early-stage development.
Rod Nuss, Validcare COO, noted the firm understands that “time and budget constraints significantly impact medical device innovation” and focuses on helping companies achieve compliant, efficient clinical execution.
About TECLens
TECLens is developing refractive vision care technology with potential applications for presbyopia, myopia prevention, and keratoconus treatment.