Author:
Arevalo J. Fernando,Al Rashaed Saba,Alhamad Tariq A.,Al Kahtani Eman,Al-Dhibi Hassan A.,Mura Marco,Al Kahtani Eman,Nowilaty Sawsan,Al Rashaed Saba,Al-Dhibi Hassan A.,Al-Zahrani Yahya A.,Kozak Igor,Al-Sulaiman Sulaiman,Al-Abdullah Abdulelah,Al-Bar Ahmad,Al Dhafiri Yousef,Al Qahtani Abdullah,Al Rubaie Khalid,Al Shahrani Saeed,Al Shehri Maha,Al Ahmadi Badr,Al Hadlaq Abdulaziz,Al Harbi Majed,Al Oreany Abdulaziz,Fernando Arevalo J.,
Abstract
Abstract
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.
Publisher
Springer Science and Business Media LLC
Reference16 articles.
1. Heckenlively J, Friederich R, Farson C, Pabalis G. Retinitis pigmentosa in the Navajo. Metab Pediatr Ophthalmol. 1981;5:201–6.
2. Hamel C. Retinitis pigmentosa. Orphanet J Rare Dis. 2006;1:40.
3. Al-Rashed M, Abu Safieh L, Alkuraya H, et al. RP1 and retinitis pigmentosa: report of novel mutations and insight into mutational mechanism. Br J Ophthalmol. 2012;96:1018–22.
4. el-Hazmi MA, al-Swailem AR, Warsy AS, et al. Consanguinity among the Saudi Arabian population. J Med Genet. 1995;32:623–6.
5. Petrs-Silva H, Linden R. Advances in gene therapy technologies to treat retinitis pigmentosa. Clin Ophthalmol. 2014;8:127–36.
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