scholarly journals One-year anatomical and functional outcomes of the Argus II implantation in Korean patients with late-stage retinitis pigmentosa: A prospective case series study

2020 ◽  
Author(s):  
Young Hee Yoon ◽  
Mark Humayun ◽  
Yoon Jeon Kim

Purpose: To report the anatomical and functional outcomes of Argus II retinal prosthesis implantation in Korean patients Methods:We included five consecutive patients with end-stage retinitis pigmentosa (RP) who underwent Argus II retinal prosthesis implantation and followed for at least 12 months. The transcorneal electrical evoked response was utilized for patient selection. We used intraoperative optical coherence tomography (OCT) for optimal placement of the array and provided specialized vision rehabilitation training. Morphological evaluation using SD-OCT and functional evaluation using computer-based visual function tests (CVFT), a letter reading ability test, and the Functional Low-Vision Observer Rated Assessment (FLORA) were conducted. Results: Postoperatively, the array was completely apposed to the retinal surface in all eyes except for one eye that had a preexisting macular concavity. Fibrosis-like tissues of ≥ 50-μm thickness developed at the interface in two eyes. All patients showed improvement in CVFT, and could read ETDRS letters at a distance of 50 cm. Three patients could read Korean words. FLORA was improved in all patients, mainly in tasks of visual mobility, daily activities, and social interactions. Conclusions: Along with good anatomical outcomes and specialized rehabilitation practices, recipients of the Argus II implant showed profound improvements in functional vision and mobility.

2017 ◽  
Vol 27 (1) ◽  
pp. 16-21 ◽  
Author(s):  
Francesco Parmeggiani ◽  
Katia De Nadai ◽  
Angela Piovan ◽  
Andrea Binotto ◽  
Sara Zamengo ◽  
...  

Purpose To report a real-life experience with the Argus II retinal prosthesis system in blind patients with end-stage retinitis pigmentosa (RP) or choroideremia (CHM), focusing on the pivotal role of optical coherence tomography (OCT) in both preoperative and postoperative management. Methods This hospital-based case series included 3 blind patients who were uneventfully implanted with Argus II epiretinal device. These patients (2 with RP and 1 with CHM) were selected during the Argus™ II Retinal Prosthesis System PostMarket Surveillance Study Protocol. Complete screening procedures had involved 66 eyes of 33 patients afferent to the Center for Retinitis Pigmentosa of the Veneto Region. Results Preoperative OCT examination resulted in the exclusion of 8 eyes in 4 patients with bilateral posterior staphyloma diagnosing unexpected staphylomatous macular patterns in 2 patients with RP and no sign of pathologic myopia. Postoperative OCT study of Argus II proximity to retinal surface indicated a plausible correlation between electrode–retina distance and perceptual threshold in 2 of our 3 patients. In particular, during the first 6 months of follow-up, the patient with the closest contact between device and macula showed a continuous vision-related improvement in the performance of several real-life tasks. Conclusions The present findings illustrate the modalities by which each different OCT examination is an essential tool to optimize safety and efficacy profiles during Argus II protocol. Optical coherence tomography will be crucial for future investigative approaches on patient selection criteria and next-generation implant design.


Author(s):  
Kh. P. Takhchidi ◽  
G. F. Kachalina ◽  
N. Kh. Takhchidi ◽  
R. A. Manoyan ◽  
P. V. Gliznitsa

The death of outer retinal layers occurring in retinitis pigmentosa causes severe visual impairment and often leads to total blindness. Inner retinal layers are spared, though, which provides a possibility of inducing visual perception by direct electrical stimulation of intact retinal cells. This article presents clinical outcomes of two patients who were the first in Russia to have received the Argus II Retinal Prosthesis System. Both implantations were successful. No complications were reported throughout the entire follow-up period. Upon completing 3 rehabilitation sessions, the patients were able to navigate indoors and outdoors, locate small high-contrast objects, discern contours of large objects and people’s silhouettes.


2019 ◽  
Author(s):  
Judith White ◽  
Laura Knight ◽  
Lyndon da Cruz ◽  
Paulo Eduardo Stanga ◽  
Hannah Patrick ◽  
...  

BACKGROUND Retinitis pigmentosa (RP) is an incurable, degenerative retinal condition causing progressive sight loss, impacting significantly on patients’ quality of life. The Argus® II Retinal Prosthesis is a surgically implanted medical device which delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision to blind people with severe to profound RP by stimulating remaining viable retinal cells to induce visual perception. This study has been initiated by NHS England’s Commissioning through Evaluation programme and funded through the UK’s National Institute of Health Research OBJECTIVE To assess the impact of the Argus II device on patient’s daily activities and quality of life. METHODS This protocol is a prospective, single arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. Patient representatives have played an integral role in the design of the study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage RP and a willingness and capacity to complete the post-implantation rehabilitation programme. Participants will be interviewed by independent researchers at baseline and 12 months later using a semi-structured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment Very Low Vision, EQ-5D-5L and EQ-VAS, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The impact of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (e.g. ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success and adverse events. Qualitative and quantitative outcomes will be linked on a single database to enable individual participant measures to be considered in toto, comparing baseline to final review. RESULTS Ethics approval has been obtained and funding has been awarded. The manufacturer recently withdrew the Argus II device from sale in the UK, therefore the study is not going ahead at this time. CONCLUSIONS The mixed method approach provides a rich and in-depth assessment of the impact of the device on participants’ quality of life. Despite the work not going ahead, publication of this publicly-funded protocol is important for researchers planning similar work. CLINICALTRIAL


2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Anil Vaidya ◽  
Elio Borgonovi ◽  
Rod S Taylor ◽  
José-Alain Sahel ◽  
Stanislao Rizzo ◽  
...  

Retina ◽  
2019 ◽  
Vol 39 ◽  
pp. S199-S200 ◽  
Author(s):  
Aleksandra Rachitskaya ◽  
Leslie Lane ◽  
Justis Ehlers ◽  
Meghan DeBenedictis ◽  
Alex Yuan

2016 ◽  
Vol Volume 10 ◽  
pp. 1565-1571 ◽  
Author(s):  
Alexandre Matet ◽  
Nawel Amar ◽  
Saddek Mohand-Said ◽  
José-Alain Sahel ◽  
Pierre-Olivier Barale

2016 ◽  
Vol 10 (4) ◽  
pp. 382-385 ◽  
Author(s):  
Paul E. Israelsen ◽  
SriniVas R. Sadda ◽  
Jessy D. Dorn ◽  
Mark S. Humayun ◽  
Lisa C. Olmos de Koo

2020 ◽  
Author(s):  
Hui-Kuang Huang ◽  
Steve K. Lee ◽  
Yi-Chao Huang ◽  
Cheng-Yu Yin ◽  
Ming-Chau Chang ◽  
...  

Abstract Background: Ulnar shortening osteotomy (USO) is an effective treatment for ulnar impaction syndrome. However, there has been a concern of osteoarthritis (OA) developing at the distal radioulnar joint (DRUJ) if USO is performed on patients with a reverse oblique sigmoid notch. This study aimed to evaluate the radiographic and functional outcomes following USO in patients with a reverse oblique sigmoid notch.Methods: We retrospectively reviewed our patients with a reverse oblique sigmoid notch who underwent USO to treat ulnar impaction syndrome between 2002 and 2013. We evaluated the radiographic changes of the DRUJ and the patients’ functional outcomes.Results: We enrolled 22 patients (22 wrists) with an average age at operation of 49.6 years and mean follow-up of 93.2 (range, 36 - 179; SD 38.2) months. We found that there were changes in the inclination angle of the sigmoid notch, from an average of reverse oblique 14.9o (range, 11o - 23o; SD 3.4o) preoperatively to a more parallel 5.1o (range, 0o - 11o; SD 3.2o) at the final follow-ups. The functional results at the final follow-ups were good with a mean VAS for pain of 0.2 (range, 0 - 1; SD 0.4) at rest and 1.3 (range, 0 - 3; SD 0.9) during activity, QuickDASH of 15.1 (range, 2.3 - 34.1; SD 8.8), and modified Mayo Wrist Score of 91.6 (range, 70-100; SD 6.4). Seven wrists (31.8%) were noted to have OA changes, but the wrists did not exhibit a significantly worse function when compared to wrists without OA changes, except for supination motion and grip strength.Conclusions: For those patients with a reverse oblique sigmoid inclination following USO, the inclination angle would have a tendency to become more parallel and some patients would develop OA changes at the DRUJ, but the functional outcomes could still be good in the long term. The reverse oblique sigmoid inclination seems not to be an absolute contraindication for USO.


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