TY - JOUR
T1 - Argus II retinal prosthesis for retinitis pigmentosa in the Middle East
T2 - The 2015 Pan-American Association of Ophthalmology Gradle Lecture
AU - Arevalo, J. Fernando
AU - Al Rashaed, Saba
AU - Alhamad, Tariq A.
AU - Al Kahtani, Eman
AU - Al-Dhibi, Hassan A.
AU - KKESH Collaborative Retina Study Group
AU - Mura, Marco
AU - Nowilaty, Sawsan
AU - Al-Dhibi, Hassan A.
AU - Al-Zahrani, Yahya A.
AU - Kozak, Igor
AU - Al-Sulaiman, Sulaiman
AU - Al-Abdullah, Abdulelah
AU - Al-Bar, Ahmad
AU - Al Dhafiri, Yousef
AU - Al Qahtani, Abdullah
AU - Al Rubaie, Khalid
AU - Al Shahrani, Saeed
AU - Al Shehri, Maha
AU - Al Ahmadi, Badr
AU - Al Hadlaq, Abdulaziz
AU - Al Harbi, Majed
AU - Al Oreany, Abdulaziz
AU - Fernando Arevalo, J.
N1 - Funding Information: We would like to acknowledge the KKESH research department and Mr. Abdulrahman AlHommadi for their efforts in the coordination of patient care on this project. Publisher Copyright: © 2021, The Author(s).
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Background: To describe the outcomes of patients with retinitis pigmentosa (RP) who received the Argus II Retinal Prosthesis System. Methods: This retrospective, interventional case series evaluated 10 consecutive patients who received the Argus II retinal implant and underwent visual function tests with the system on and system off. The main outcome measures were safety (the number, seriousness, and relatedness of adverse events), and visual function measured by computer-based objective tests, including square localization (SL) and direction of motion (DOM). Secondary measures included functional vision performance, including orientation and mobility (O&M) tasks. Results: There were no intraoperative complications and all prostheses remained implanted at the end of follow up. The mean patient age was 41.3 years; mean duration of the implant in vivo was 2.1 years. One patient had a suture exposure over the coil suture tab and over the inferior case suture tab at 2 years postoperatively, which was managed successfully. One patient developed mild vitreous hemorrhage that resolved spontaneously. One patient developed high intraocular pressure postoperatively due to a tight scleral band (SB) that was managed successfully. Patients performed significantly better with the Argus II system on than off on all tasks. Conclusion: Patients who received the Argus II had a safety profile out to 4 years post-implantation that was markedly better than that observed in the pre-approval phase of the Argus II. In this population of RP patients, the Argus II retinal prosthesis provided useful visual function over several years that likely translates into improved quality of life. Trial Registration: clinicaltrials.gov identifier, NCT00407602.
AB - Background: To describe the outcomes of patients with retinitis pigmentosa (RP) who received the Argus II Retinal Prosthesis System. Methods: This retrospective, interventional case series evaluated 10 consecutive patients who received the Argus II retinal implant and underwent visual function tests with the system on and system off. The main outcome measures were safety (the number, seriousness, and relatedness of adverse events), and visual function measured by computer-based objective tests, including square localization (SL) and direction of motion (DOM). Secondary measures included functional vision performance, including orientation and mobility (O&M) tasks. Results: There were no intraoperative complications and all prostheses remained implanted at the end of follow up. The mean patient age was 41.3 years; mean duration of the implant in vivo was 2.1 years. One patient had a suture exposure over the coil suture tab and over the inferior case suture tab at 2 years postoperatively, which was managed successfully. One patient developed mild vitreous hemorrhage that resolved spontaneously. One patient developed high intraocular pressure postoperatively due to a tight scleral band (SB) that was managed successfully. Patients performed significantly better with the Argus II system on than off on all tasks. Conclusion: Patients who received the Argus II had a safety profile out to 4 years post-implantation that was markedly better than that observed in the pre-approval phase of the Argus II. In this population of RP patients, the Argus II retinal prosthesis provided useful visual function over several years that likely translates into improved quality of life. Trial Registration: clinicaltrials.gov identifier, NCT00407602.
KW - Argus II
KW - Blindness
KW - Functional vision
KW - Retinal prosthesis
KW - Retinitis pigmentosa
UR - http://www.scopus.com/inward/record.url?scp=85118238612&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s40942-021-00324-6
DO - https://doi.org/10.1186/s40942-021-00324-6
M3 - Article
C2 - 34706764
SN - 2056-9920
VL - 7
JO - International Journal of Retina and Vitreous
JF - International Journal of Retina and Vitreous
IS - 1
M1 - 65
ER -