Szurman and colleagues presented a first-in-human, prospective, multicenter clinical investigation to assess the safety, tolerability and performance of the EYEMATE-SC suprachoroidal intraocular pressure (IOP) sensor in 24 patients with open angle glaucoma (OAG) undergoing non-penetrating glaucoma surgery (NPGS). The EYEMATE-SC was developed to overcome the limitations of the preceding sulcus-implant sensor (EYEMATE-IO). The EYEMATE-SC was successfully implanted in all study eyes. No serious adverse event or device malfunction was observed throughout the 6 months study period. The measured IOP values of the EYEMATE-SC showed good agreement with that of Goldmann applanation tonometry (GAT) at 3 and 6 months postoperatively (average difference of 0.15mmHg at 6 months), although the agreement was relatively poor at early postoperative period.
While the data provided by the paper are promising, relatively small and heterogenous participant population limits the generalizability of the results. In particular, the sample size is not sufficient to assess the possibility of causing rare but critical adverse events such as choroidal hemorrhage. The accuracy of EYEMATE-SC measurements was evaluated by comparisons with GAT measurements. However, GAT may not be an optimal reference standard for evaluating the accuracy of IOP measurement in eyes with altered corneal biomechanics. Future research evaluating the agreement between EYEMATE-SC measurements and direct intraocular IOP measurements is necessary. In addition, many other critical questions such as the safety and performance of the implantation as a stand-alone procedure, longer-term safety and performance, and influence of various clinical factors such as disease type, IOP values, and corneal properties on the accuracy of the sensor readings, remain unanswered.
The study demonstrates the potential of the EYEMATE-SC as a new device to fill the unmet need for continuous IOP monitoring
Although the results of the study will need to be confirmed in future larger and longer-term studies, the study demonstrates the potential of the EYEMATE-SC as a new device to fill the unmet need for continuous IOP monitoring.