Comparison of two prototypes of a magnetically adjustable glaucoma implant in rabbits.

Glaucoma drainage devices are used in surgical glaucoma therapy. Success of controlling the intraocular pressure is limited due to fibrous implant encapsulation and fibrin coating on the implant which lead to drainage obstructions. An innovative implant with a magnetically adjustable valve was developed. The valve opening of the implant should eliminate inflammatory products from the outflow area and affect fibrous tissue formation to achieve a sufficient long-term aqueous humour outflow. Lifting of this valve should disturb cell adhesion by exerting mechanical forces. Before testing this hypothesis, the flow characteristics of glaucoma drainage devices, especially the outflow resistance by regular IOP, should be considered in a pilot study, as they are important in preventing too low postoperative intraocular pressure known as ocular hypotony. Therefore, two prototypes of the innovative implant differing in their valve area design were examined regarding their flow characteristics in a limited animal experiment lasting two weeks. Ten healthy New Zealand White rabbits were divided into two groups (A & B) with different implanted prototypes. Daily, tonometry and direct ophthalmoscopy were performed to assess the intraocular pressure and the inflammatory reaction of the eye. After two weeks, the rabbits were euthanised to evaluate the initially histological inflammatory reaction to the implant. In group A, one case of hypotony emerged. When considering the entire observation period, a highly statistically significant difference between the intraocular pressure in the operated eye and that in the control eye was detected in group A (p < 0.0001) in contrast to group B (p = 0.0063). The postoperative inflammatory signs decreased within two weeks. Histologically, a typical but low level foreign body reaction with macrophages and lymphocytes as well as mild to moderate fibrosis was seen after the short experimental period. Based on our tonometric results, prototype B seems to be the system of choice for further research assessing its long-term function and biocompatibility.

Evaluation of the static magnetic field interactions for a newly developed magnetic ophthalmic implant at 3 Tesla MRI. / Untersuchung der Wirkungen eines statischen Magnetfeldes auf ein neu-entwickeltes magnetisch ophthalmologisches Implantat in einem 3 Tesla MRT.

PURPOSE: The purpose of this study is to analyze the static magnetic field interactions for an ophthalmic-magnetic shunt implant with a ferromagnetic steel plate in a thin silicon layer. The plate is used for opening of a valve flap. Ten different sizes of this steel plate were investigated to characterize the relationship between the size of the metal and the magnetic forces of the static magnetic field of a 3.0 T MRI. MATERIALS AND METHODS: The magnetic translation force Fz was quantified by determining the deflection angle using the deflection angle test (ASTM F 2052). The torque was qualitatively estimated by using a 5-point grading scale (0: no torque; + 4: very strong torque) according to Sommer et al. 11. For the visual investigation of the function of the metal plate both prototypes were positioned at the magnetic field's spatial gradient and at the magnet's isocenter. The stitches were exposed to the thousandfold of the translational force by a dynamometer. RESULTS: The translational force was found to be 10 times greater than the weight of a single plate. The plates were exposed to a high torque (grade 3 to 4). The seams and the tissue withstood more than a thousandfold of the determined translational force. No spontaneous, uncontrolled opening of the valve flap was visible in the MRI, as a result of which the intraocular pressure could decrease considerably. CONCLUSION: Due to the small size of the plates the translational force and the torque will be compensated by the silicon layer and also by the fixation in the eye. KEY POINTS: · Magnetic forces will be compensated by silicon layer and fixation in the eye.. · The magnetic-ophthalmological implant is not restricted in its function by the MRI magnetic field.. · The ophthalmic magnetic shunt implant can be considered conditionally MRI-safe.. CITATION FORMAT: · Bodenstein A, Lüpke M, Seiler C et al. Evaluation of the static magnetic field interactions for a newly developed magnetic ophthalmic implant at 3 Tesla MRI. Fortschr Röntgenstr 2019; 191: 209 - 215.

Comparison of Six Different Silicones In Vitro for Application as Glaucoma Drainage Device.

Silicones are widely used in medical applications. In ophthalmology, glaucoma drainage devices are utilized if conservative therapies are not applicable or have failed. Long-term success of these devices is limited by failure to control intraocular pressure due to fibrous encapsulation. Therefore, different medical approved silicones were tested in vitro for cell adhesion, cell proliferation and viability of human Sclera (hSF) and human Tenon fibroblasts (hTF). The silicones were analysed also depending on the sample preparation according to the manufacturer's instructions. The surface quality was characterized with environmental scanning electron microscope (ESEM) and water contact angle measurements. All silicones showed homogeneous smooth and hydrophobic surfaces. Cell adhesion was significantly reduced on all silicones compared to the negative control. Proliferation index and cell viability were not influenced much. For development of a new glaucoma drainage device, the silicones Silbione LSR 4330 and Silbione LSR 4350, in this study, with low cell counts for hTF and low proliferation indices for hSF, and silicone Silastic MDX4-4210, with low cell counts for hSF and low proliferation indices for hTF, have shown the best results in vitro. Due to the high cell adhesion shown on Silicone LSR 40, 40,026, this material is unsuitable.

Osteointegration of Porous Poly-ε-Caprolactone-Coated and Previtalised Magnesium Implants in Critically Sized Calvarial Bone Defects in the Mouse Model.

Metallic biomaterials are widely used in maxillofacial surgery. While titanium is presumed to be the gold standard, magnesium-based implants are a current topic of interest and investigation due to their biocompatible, osteoconductive and degradable properties. This study investigates the effects of poly-ε-caprolactone-coated and previtalised magnesium implants on osteointegration within murine calvarial bone defects: After setting a 3 mm × 3 mm defect into the calvaria of 40 BALB/c mice the animals were treated with poly-ε-caprolactone-coated porous magnesium implants (without previtalisation or previtalised with either osteoblasts or adipose derived mesenchymal stem cells), porous Ti6Al4V implants or without any implant. To evaluate bone formation and implant degradation, micro-computertomographic scans were performed at day 0, 28, 56 and 84 after surgery. Additionally, histological thin sections were prepared and evaluated histomorphometrically. The outcomes revealed no significant differences within the differently treated groups regarding bone formation and the amount of osteoid. While the implant degradation resulted in implant shifting, both implant geometry and previtalisation appeared to have positive effects on vascularisation. Although adjustments in degradation behaviour and implant fixation are indicated, this study still considers magnesium as a promising alternative to titanium-based implants in maxillofacial surgery in future.