Smartlens, Inc. announced positive results from a clinical study conducted on its non-invasive contact lens: miLens.
Tell me about this company first.
California-based Smartlens, Inc. is an ophthalmic medical technology company with a portfolio of clinical-stage technologies for glaucoma, including a unique platform that could enable early diagnosis and prevention for disease progression.
In addition to the miLens, its flagship product, the company has also developed THERmic, a next-generation, non-invasive, and adaptive drug delivery technology that monitors efficacy and provides personalized therapies for individual patients.
Give me more details on the miLens.
Based on a prototype glaucoma-monitoring implant previously developed at Stanford University, the novel contact lens-based technology is designed to monitor intraocular pressure (IOP), anywhere and anytime.
The soft contact lens system (miLens) is a multiple-layer medical device composed of a silicone hydrogel material that is 200 microns thick.
It uses Smartlens’s electronics-free sensor technology, which, according to the company, is currently being studied at Stanford to also monitor intracranial pressure (ICP) associated with neurological disorders.
Now talk about this trial.
The clinical study assessed the comfort and accuracy of the miLens versus Goldmann applanation tonometry (GAT), the current standard for IOP measurement), and rebound tonometry (iCare 200) in 25 patients (ages 24-50 years) free from ocular pathology with visual acuity of 20/25 or better..
Only study participants found to have inter-eye IOP measurements of <2 mmHg were included in the study.
Further, miLens was inserted in the study eye while the fellow eye was used as a control. The latter was evaluated hourly for IOP measurements using both GAT and rebound tonometry. All participants received oral acetazolamide 250 mg after two hours.
Subsequently, IOP was measured 30 minutes thereafter in the fellow eye for the next two hours. After four hours, miLens was removed from the study eye and IOP was measured in both eyes.
What did they find?
Overall, a significant and statistically strong positive correlation was noted between IOP measurements taken using the miLens versus those measured using the Goldmann tonometer.
According to the company, the IOP changes miLens measured were also consistent with that of the GAT IOP values—an indication of miLens’ ability to monitor IOP over time.
Click here to watch the presentation of findings, presented by Pinakin G. Davey, OD, and James C. Tsai, MD, MBA, at the 2023 American Glaucoma Society meeting.
Give me some numbers.
A strong correlation was noted between the miLens and GAT, with 78% of miLens measurements being within +2 mmHg of the GAT measurements.
Additionally, 70% of miLens IOP values were within +2 mmHg of rebound tonometry measurements.
Any adverse effects?
According to the company, no major adverse events were reported.
Significance?
According to CEO Savas Komban, the miLens has the potential to advance and transform glaucoma care through convenient and reliable IOP monitoring—leading to significant improvement for patient outcomes.