Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study

被引:29
|
作者
Abbott, Carla J. [1 ,2 ]
Nayagam, David A. X. [3 ,4 ]
Luu, Chi D. [1 ,2 ]
Epp, Stephanie B. [3 ]
Williams, Richard A. [4 ,5 ]
Salinas-LaRosa, Cesar M. [4 ,5 ]
Villalobos, Joel [3 ]
McGowan, Ceara [3 ]
Shivdasani, Mohit N. [3 ,6 ]
Burns, Owen [3 ]
Leavens, Jason [7 ]
Yeoh, Jonathan [1 ,2 ]
Brandli, Alice A. [1 ,8 ]
Thien, Patrick C. [3 ,9 ]
Zhou, Jenny [3 ]
Feng, Helen [3 ]
Williams, Chris E. [3 ,9 ]
Shepherd, Robert K. [3 ,9 ]
Allen, Penelope J. [1 ,2 ]
机构
[1] Royal Victorian Eye & Ear Hosp, Ctr Eye Res Australia, East Melbourne, Australia
[2] Univ Melbourne, Dept Surg Ophthalmol, Melbourne, Vic, Australia
[3] Bion Inst, East Melbourne, Australia
[4] Univ Melbourne, Dept Pathol, Melbourne, Vic, Australia
[5] St Vincents Hosp Melbourne, Fitzroy, Vic, Australia
[6] Univ New South Wales, Grad Sch Biomed Engn, Sydney, NSW, Australia
[7] Cochlear Ltd, Sydney, NSW, Australia
[8] Univ Melbourne, Dept Anat & Neurosci, Melbourne, Vic, Australia
[9] Univ Melbourne, Med Bion Dept, Melbourne, Vic, Australia
基金
英国医学研究理事会; 澳大利亚国家健康与医学研究理事会;
关键词
retinal prosthesis; optical coherence tomography; electroretinography; retinal histology; retinal safety; ELECTRICAL-STIMULATION; ANGIOGRAPHIC FINDINGS; IN-VIVO; VISION; IMPLANTS; PERFORMANCE; ANIMALS; SYSTEM; TRIAL;
D O I
10.1167/iovs.17-23086
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
PURPOSE. Following successful clinical outcomes of the prototype suprachoroidal retinal prosthesis, Bionic Vision Australia has developed an upgraded 44-channel suprachoroidal retinal prosthesis to provide a wider field of view and more phosphenes. The aim was to evaluate the preclinical passive safety characteristics of the upgraded electrode array. METHODS. Ten normal-sighted felines were unilaterally implanted with an array containing platinum electrodes (44 stimulating and 2 returns) on a silicone carrier near the area centralis. Clinical assessments (color fundus photos, optical coherence tomography, full-field electroretinography, intraocular pressure) were performed under anesthesia prior to surgery, and longitudinally for up to 20 weeks. Histopathology grading of fibrosis and inflammation was performed in two animals at 13 to 15 weeks. RESULTS. Eight animals showed safe electrode array insertion (good retinal health) and good conformability of the array to the retinal curvature. Eight animals demonstrated good mechanical stability of the array with only minor (<2 disc diameters) lateral movement. Four cases of surgical or stability complications occurred due to (1) bulged choroid during surgery, (2) hemorrhage from a systemic bleeding disorder, (3) infection, and (4) partial erosion of thin posterior sclera. There was no change in retinal structure or function (other than that seen at surgery) at endpoint. Histopathology showed a mild foreign body response. Electrodes were intact on electrode array removal. CONCLUSIONS. The 44-channel suprachoroidal electrode array has an acceptable passive safety profile to proceed to clinical trial. The safety profile is expected to improve in human studies, as the complications seen are specific to limitations (anatomic differences) with the feline model.
引用
收藏
页码:1410 / 1424
页数:15
相关论文
共 41 条
  • [1] Passive safety outcomes of a preclinical 44-channel suprachoroidal retinal prosthesis
    Abbott, Carla J.
    Luu, Chi D.
    Nayagam, David A. X.
    Brandli, Alice
    Yeoh, Jonathan
    Villalobos, Joel
    Burns, Owen
    Epp, Stephanie B.
    Shivdasani, Mohit Naresh
    Thien, Patrick C.
    McGowan, Ceara
    Williams, Richard
    Guymer, Robyn H.
    Williams, Chris E.
    Shepherd, Robert K.
    Allen, Penelope J.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2017, 58 (08)
  • [2] SAFETY OF A 44-CHANNEL SUPRACHOROIDAL RETINAL PROSTHESIS IN A FELINE MODEL
    Abbott, Carla J.
    Luu, Chi D.
    Brandli, Alice
    Yeoh, Jonathan
    Ayton, Lauren N.
    Nayagam, David Ax
    Shivdasani, Mohit N.
    Villalobos, Joel
    Burns, Owen
    Epp, Stephanie B.
    Thien, Patrick C.
    McGowan, Ceara
    Williams, Chris E.
    Shepherd, Robert K.
    Guymer, Robyn H.
    Allen, Penelope J.
    [J]. CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY, 2016, 44 : 32 - 32
  • [3] Oculomotor Responses to Dynamic Stimuli in a 44-Channel Suprachoroidal Retinal Prosthesis
    Titchener, Samuel A.
    Kvansakul, Jessica
    Shivdasani, Mohit N.
    Fallon, James B.
    Nayagam, D. A. X.
    Epp, Stephanie B.
    Williams, Chris E.
    Barnes, Nick
    Kentler, William G.
    Kolic, Maria
    Baglin, Elizabeth K.
    Ayton, Lauren N.
    Abbott, Carla J.
    Luu, Chi D.
    Allen, Penelope J.
    Petoe, Matthew A.
    [J]. TRANSLATIONAL VISION SCIENCE & TECHNOLOGY, 2020, 9 (13): : 1 - 13
  • [4] Functional vision in the real-world environment with a 44-channel suprachoroidal retinal prosthesis
    Karapanos, Lewis
    Abbott, Carla J.
    Ayton, Lauren N.
    Kolic, Maria
    McGuinness, Myra
    Baglin, Elizabeth K.
    Titchener, Samuel A.
    Kvansakul, Jessica
    Johnson, Dean
    Kentler, William G.
    Barnes, Nick
    Nayagam, David A. X.
    Petoe, Matthew A.
    Allen, Penelope J.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2021, 62 (08)
  • [5] A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: Interim Clinical Trial Results
    Petoe, Matthew A.
    Titchener, Samuel A.
    Kolic, Maria
    Kentler, William G.
    Abbott, Carla J.
    Nayagam, David A. X.
    Baglin, Elizabeth K.
    Kvansakul, Jessica
    Barnes, Nick
    Walker, Janine G.
    Epp, Stephanie B.
    Young, Kiera A.
    Ayton, Lauren N.
    Luu, Chi D.
    Allen, Penelope J.
    [J]. TRANSLATIONAL VISION SCIENCE & TECHNOLOGY, 2021, 10 (10):
  • [6] A 44 channel suprachoroidal retinal prosthesis : surgical approach, safety and stability
    Allen, Penelope J.
    Nayagam, David A. X.
    Epp, Stephanie B.
    Luu, Chi D.
    Barnes, Nick
    Kolic, Maria
    Young, Kiera A.
    Baglin, Elizabeth Kate
    Abbott, Carla J.
    Briggs, Robert
    Yeoh, Jonathan
    Kentler, William G.
    Titchener, Samuel A.
    Petoe, Matthew A.
    Williams, Chris E.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2019, 60 (09)
  • [7] A Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis: A Single-Arm Clinical Trial of Feasibility
    Petoe, Matthew A.
    Abbott, Carla J.
    Titchener, Samuel A.
    Kolic, Maria
    Kentler, William G.
    Nayagam, David A. X.
    Baglin, Elizabeth K.
    Kvansakul, Jessica
    Barnes, Nick
    Walker, Janine G.
    Karapanos, Lewis
    McGuinness, Myra B.
    Ayton, Lauren N.
    Luu, Chi D.
    Allen, Penelope J.
    [J]. OPHTHALMOLOGY SCIENCE, 2025, 5 (01):
  • [8] A 44 Channel suprachoroidal retinal prosthesis : two year safety and stability results
    Allen, Penelope J.
    Nayagam, David A. X.
    Epp, Stephanie
    Luu, Chi D.
    Barnes, Nick
    Kolic, Maria
    Baglin, Elizabeth K.
    Abbott, Carla J.
    Briggs, Robert
    Yeoh, Jonathan
    Kentler, William G.
    Kvansakul, Jessica
    Titchener, Samuel A.
    Petoe, Matthew A.
    Williams, Christopher E.
    [J]. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE, 2021, 62 (08)
  • [9] Functional Vision in the Real-World Environment With a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis
    Karapanos, Lewis
    Abbott, Carla J.
    Ayton, Lauren N.
    Kolic, Maria
    McGuinness, Myra B.
    Baglin, Elizabeth K.
    Titchener, Samuel A.
    Kvansakul, Jessica
    Johnson, Dean
    Kentler, William G.
    Barnes, Nick
    Nayagam, David A. X.
    Allen, Penelope J.
    Petoe, Matthew A.
    [J]. TRANSLATIONAL VISION SCIENCE & TECHNOLOGY, 2021, 10 (10):
  • [10] Interobserver Agreement of Electrode to Retina Distance Measurements in a Second-Generation (44-Channel) Suprachoroidal Retinal Prosthesis
    Abbott, Carla J.
    Baglin, Elizabeth K.
    Kolic, Maria
    McGuinness, Myra B.
    Titchener, Samuel A.
    Young, Kiera A.
    Yeoh, Jonathan
    Luu, Chi D.
    Ayton, Lauren N.
    Petoe, Matthew A.
    Allen, Penelope J.
    [J]. TRANSLATIONAL VISION SCIENCE & TECHNOLOGY, 2022, 11 (09):