Reliable intraocular pressure measurement using automated radio-wave telemetry

Eleftherios I Paschalis,* Fabiano Cade,* Samir Melki, Louis R Pasquale, Claes H Dohlman, Joseph B CiolinoMassachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA*These authors contributed equally to this workPurpose: To present an autonomous intraocular pressure (IOP) measurement technique using a wireless implantable transducer (WIT) and a motion sensor.Methods: The WIT optical aid was implanted within the ciliary sulcus of a normotensive rabbit eye after extracapsular clear lens extraction. An autonomous wireless data system (AWDS) comprising of a WIT and an external antenna aided by a motion sensor provided continuous IOP readings. The sensitivity of the technique was determined by the ability to detect IOP changes resulting from the administration of latanoprost 0.005% or dorzolamide 2%, while the reliability was determined by the agreement between baseline and vehicle (saline) IOP.Results: On average, 12 diurnal and 205 nocturnal IOP measurements were performed with latanoprost, and 26 diurnal and 205 nocturnal measurements with dorzolamide. No difference was found between mean baseline IOP (13.08±2.2 mmHg) and mean vehicle IOP (13.27±2.1 mmHg) (P=0.45), suggesting good measurement reliability. Both antiglaucoma medications caused significant IOP reduction compared to baseline; latanoprost reduced mean IOP by 10% (1.3±3.54 mmHg; P<0.001), and dorzolamide by 5% (0.62±2.22 mmHg; P<0.001). Use of latanoprost resulted in an overall twofold higher IOP reduction compared to dorzolamide (P<0.001). Repeatability was ±1.8 mmHg, assessed by the variability of consecutive IOP measurements performed in a short period of time (≤1 minute), during which the IOP is not expected to change.Conclusion: IOP measurements in conscious rabbits obtained without the need for human interactions using the AWDS are feasible and provide reproducible results.Keywords: IOP, pressure transducer, wireless, MEMS, implant, intraocula

Thin minimal rim width at Bruch’s membrane opening is associated with glaucomatous paracentral visual field loss

Elise V Taniguchi,1–3 Eleftherios I Paschalis,1,2 Dejiao Li,1,4 Kouros Nouri-Mahdavi,5 Stacey C Brauner,1 Scott H Greenstein,1 Angela V Turalba,1 Janey L Wiggs,1 Louis R Pasquale,1,6 Lucy Q Shen1 1Department of Ophthalmology, Harvard Medical School, Massachusetts Eye and Ear, Boston, MA, 2Boston Keratoprosthesis Laboratory, Massachusetts Eye and Ear – Schepens Eye Research Institute, Harvard Medical School, Boston, MA, USA; 3Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil; 4Department of Ophthalmology, Beijing China-Japan Friendship Hospital, Beijing, People’s Republic of China; 5Department of Ophthalmology, David Geffen School of Medicine and Stein Eye Institute, Los Angeles, CA, USA; 6Channing Division of Network Medicine, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA Purpose: To compare optic nerve head (ONH) measurements in glaucomatous eyes with paracentral visual field (VF) loss to eyes with peripheral VF loss and controls.Methods: Open-angle glaucoma (OAG) patients with early paracentral VF loss or isolated peripheral VF loss as well as control subjects underwent ONH imaging with swept-source optical coherence tomography (OCT) and retinal nerve fiber layer (RNFL) imaging with spectral-domain OCT. Minimum rim width at Bruch’s membrane opening (BMO-MRW), lamina cribrosa depth (LCD), and RNFL thickness were compared among the glaucoma and control groups with one-way analysis of variance, Kruskal–Wallis test, and multiple regression analysis.Results: Twenty-nine eyes from 29 OAG patients (15 early paracentral and 14 isolated peripheral VF loss) and 20 eyes of 20 control subjects were included. The early paracentral and isolated peripheral VF loss groups had similar VF mean deviation (MD) (–5.3±2.7 dB and –3.7±3.0 dB, p=0.15, respectively). Global BMO-MRW was lower in OAG eyes than in controls (193.8±40.0 vs 322.7±62.2 µm, p<0.001), but similar between eyes with early paracentral VF loss and those with isolated peripheral VF loss (187.6±43.4 vs 200.6±36.3 µm; p>0.99). In contrast, the minimal BMO-MRW was lower in eyes with early paracentral loss (69.0±33.6 µm) than in eyes with isolated peripheral loss (107.7±40.2 µm; p=0.03) or control eyes (200.1±40.8 µm; p<0.001). Average and thinnest RNFL thickness did not differ between OAG groups (p=0.61 and 0.19, respectively). Horizontal and vertical LCD did not differ among the OAG groups and controls (p=0.80 and 0.82, respectively). Multivariable linear regression analysis among OAG cases confirmed the association between lower minimal BMO-MRW and early paracentral VF loss (β=–38.3 µm; 95% confidence interval, –69.8 to –6.8 µm; p=0.02) after adjusting for age, gender, MD, and disc size.Conclusion: Thin minimal BMO-MRW may represent a new structural biomarker associated with early glaucomatous paracentral VF loss. Keywords: paracentral loss, BMO-MRW, open angle glaucoma, optic nerve damage, swept-source OC

Electron Beam Sterilization of Poly(Methyl Methacrylate)—Physicochemical and Biological Aspects

Electron beam (E-beam) irradiation is an attractive and efficient method for sterilizing clinically implantable medical devices made of natural and/or synthetic materials such as poly(methyl methacrylate) (PMMA). As ionizing irradiation can affect the physicochemical properties of PMMA, understanding the consequences of E-beam sterilization on the intrinsic properties of PMMA is vital for clinical implementation. A detailed assessment of the chemical, optical, mechanical, morphological, and biological properties of medical-grade PMMA after E-beam sterilization at 25 and 50 kiloGray (kGy) is reported. Fourier transform infrared spectroscopy, thermogravimetric analysis, and differential scanning calorimetry studies indicate that E-beam irradiation has minimal effect on the chemical properties of the PMMA at these doses. While 25 kGy irradiation does not alter the mechanical and optical properties of the PMMA, 50 kGy reduces the flexural strength and transparency by 10% and 2%, respectively. Atomic force microscopy demonstrates that E-beam irradiation reduces the surface roughness of PMMA in a dose dependent manner. Live-Dead, AlamarBlue, immunocytochemistry, and complement activation studies show that E-beam irradiation up to 50 kGy has no adverse effect on the biocompatibility of the PMMA. These findings suggest that E-beam irradiation at 25 kGy may be a safe and efficient alternative for PMMA sterilization