Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study

Area of Science:

• Ophthalmology
• Glaucoma Research
• Medical Device Technology

Background:

• Open-angle glaucoma management often requires continuous intraocular pressure (IOP) control.
• Nocturnal IOP fluctuations can impact disease progression.
• Novel therapeutic approaches are needed to optimize IOP management.

Purpose of the Study:

• To evaluate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
• To assess the efficacy of the MPD in reducing intraocular pressure (IOP) in patients with open-angle glaucoma.

Main Methods:

• A prospective, open-label, randomized, single-site study.
• Twenty eyes of 10 subjects with open-angle glaucoma were fitted with an MPD.
• Negative pressure of -10 mmHg was applied overnight for seven consecutive days, with safety measures including IOP, best-corrected visual acuity (BCVA), and adverse event monitoring.

Main Results:

• Initial application of -10 mmHg negative pressure reduced mean IOP by 22% (p<0.01).
• After seven consecutive nights of wear, mean IOP remained significantly reduced while wearing the MPD, in addition to current treatments.
• No statistically significant changes in IOP or BCVA were observed following the 7-day wear period, and patient-reported outcomes were favorable.

Conclusions:

• The multi-pressure dial (MPD) is safe and well-tolerated for overnight use.
• The MPD achieved a clinically and statistically significant IOP reduction exceeding 20%, augmenting existing therapies.
• The MPD presents a promising new treatment option for controlling nocturnal intraocular pressure in glaucoma patients.