ABSTRACT
PURPOSE: The aim of this study was to investigate the safety and performance of the second generation of an implantable intraocular pressure (IOP) sensor in patients with primary open angle glaucoma (POAG). DESIGN: prospective, noncomparative, open-label, multicenter clinical investigation. METHODS: In this study, patients with POAG, regularly scheduled for cataract surgery, were implanted with a ring-shaped, sulcus-placed, foldable IOP sensor in a single procedure after intraocular lens implantation. Surgical complications as well as adverse events (AEs) during 12 months of follow-up were recorded. At each follow-up visit, a complete ophthalmic examination, including visual acuity, IOP, slit lamp examination, and dilated funduscopy as well as comparative measurements between Goldmann applanation tonometry and the EYEMATE-IO implant were performed. RESULTS: The EYEMATE-IO implant was successfully implanted in 22 patients with few surgical complications and no unexpected device-related AEs. All ocular AEs resolved quickly under appropriate treatment. Comparative measurements showed good agreement between EYEMATE-IO and Goldmann applanation tonometry (GAT) with an intraclass correlation coefficient (ICC(3,k)) of 0.783 (95% confidence interval [CI]: 0.743, 0.817). EYEMATE-IO measurements were higher than GAT, with a mean difference of 3.2 mm Hg (95% CI: 2.8, 3.5 mm Hg). CONCLUSIONS: The EYEMATE-IO sensor was safely implanted in 22 patients and performed reliably until the end of follow-up. This device allows for continual and long-term measurements of IOP.
Subject(s)
Biosensing Techniques/instrumentation , Glaucoma, Open-Angle/diagnosis , Intraocular Pressure/physiology , Telemetry/methods , Tonometry, Ocular/instrumentation , Aged , Electrodes, Implanted , Equipment Design , Female , Glaucoma, Open-Angle/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Visual AcuityABSTRACT
PURPOSE: To evaluate the safety and tolerability of intravitreal ISTH0036, an antisense oligonucleotide selectively targeting transforming growth factor beta 2 (TGF-ß2), in patients with primary open angle glaucoma (POAG) undergoing trabeculectomy (TE; glaucoma filtration surgery). METHODS: In this prospective phase I trial glaucoma patients scheduled for TE with mitomycin C (MMC) received a single intravitreal injection of ISTH0036 at the end of surgery in escalating total doses of 6.75 µg, 22.5 µg, 67.5 µg or 225 µg, resulting in calculated intraocular ISTH0036 concentrations in the vitreous humor of approximately 0.3 µM, 1 µM, 3 µM or 10 µM after injection, respectively. Outcomes assessed included: type and frequency of adverse events (AEs), intraocular pressure (IOP), numbers of interventions post trabeculectomy, bleb survival, visual acuity, visual field, electroretinogram (ERG), slit lamp biomicroscopy and optic disc assessment. RESULTS: In total, 12 patients were treated in the 4 dose groups. Main ocular AEs observed were corneal erosion, corneal epithelium defect, or too high or too low IOP, among others. No AE was reported to be related to ISTH0036. All other safety-related analyses did not reveal any toxicities of concern, either. The mean medicated preoperative IOP at decision time-point for surgery was 27.3 mmHg +/- 12.6 mmHg (SD). Mean IOP (±SD) for dose levels 1, 2, 3, and 4 were at Day 43 9.8 mmHg ± 1.0 mmHg, 11.3 mmHg ± 6.7 mmHg, 5.5 mmHg ± 3.0 mmHg and 7.5 mmHg ± 2.3 mmHg SD; and at Day 85 9.7 mmHg ± 3.3 mmHg, 14.2 mmHg ± 6.5 mmHg, 5.8 mmHg ± 1.8 mmHg and 7.8 mmHg ± 0.6 mmHg, respectively. In contrast to IOP values for dose levels 1 and 2, IOP values for dose levels 3 and 4 persistently remained below 10 mmHg throughout the observation period. CONCLUSION: This first-in-human trial demonstrates that intravitreal injection of ISTH0036 at the end of TE is safe. Regarding IOP control, single-dose ISTH0036 administration of 67.5 µg or 225 µg at the time of TE resulted in IOP values persistently < 10 mmHg over the three month postoperative observation period.
