The first patient has received treatment in a first-in-human (FIH) clinical trial evaluating TECLens, Inc.’s quantitative corneal crosslinking (qCXL) technology for non-invasive refractive vision correction.
A FIH trial?! Lots to discuss … let’s take it from the top.
To refresh: TECLens is a clinical-stage ophthalmic medical device company developing personalized, noninvasive corneal CXL treatments.
- See here for a look at its executive team (and last year’s $9.3 million in funding raised).
- And check out the details on its funding from Johnson & Johnson Innovation.
Next: Tell me about this qCXL technology.
qCXL is a noninvasive, in-office procedure that delivers ultraviolet (UV) light directly to the eye via a fiber optic-connected scleral contact lens.
Key to this proprietary tech is the CXLens—a device directly applied to the scleral surface of the eye following topical administration of riboflavin (Vitamin B2) ophthalmic solution.
- Once applied, the CXLens releases a pre-calculated pattern and dose of UV light that “crosslinks” (illuminates) specific, selected zones of the cornea.
Then what happens?
That’s where the real-time monitoring of this UV light delivery kicks in as it tracks corneal responses via an integrated ultrasound (to confirm adherence to a patient’s treatment plan).
- Per TEClens, this ultrasound monitor enables precise control of cornea shape and accurate refractive outcomes.
- See here for the biomechanical properties that are measured.
And how long does this take?
Reportedly, around 30 minutes. See here for a visual of the entire six-step process.
So, in a nutshell?
Designed as an alternative to traditional surgical refractive procedures, TEClens’ qCXL and proprietary CXLens system create new molecular bonds in precise locations that, in turn, strengthen the cornea and reshape it to improve vision.
As CEO Thomas Dunlap stated: “Our qCXL technology has the potential to expand treatment options for millions of patients as a first-line treatment for vision correction for both refractive errors and presbyopia.”
- See the benefits for patients (and click here for the advantages for clinicians).
Alrighty, now what do we know about this FIH trial?
Not much at the moment (and yes, we reached out to the company for more details).
What we do know are two items:
- The purpose: To evaluate the safety and efficacy of TECLens’ qCXL technology and CXLens system.
- The participants: Will include patients with refractive errors (particularly presbyopia correction)
That’s it? Nothing on its setup or a timeframe for data?
Unfortunately, no. The company is reportedly planning to slowly roll out more details on the study once it has additional patients and is further along.
We’ll keep you posted on developments.