Dataset Information

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.

ABSTRACT: PURPOSE:To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients. DESIGN:Prospective, noncomparative cohort study. METHODS:Setting: International multicenter study. PATIENTS:Argus II recipients enrolled in the Post-Market Surveillance Studies. PROCEDURES:Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc-array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months. MAIN OUTCOME MEASURES:Axial retinal thickness and axial gap along the array's long axis (a line between the tack and handle); maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle. RESULTS:Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (P = .007). The rate of maximal thickness increase was highest near the array midline (slope = 6.02, P = .004), compared to the tack (slope = 3.60, P < .001) or the handle (slope = 1.93, P = .368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (P = .032). Optic disc-array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation. CONCLUSIONS:Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.

SUBMITTER: Gregori NZ

PROVIDER: S-EPMC6535141 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.

Gregori Ninel Z NZ Callaway Natalia F NF Hoeppner Catherine C Yuan Alex A Rachitskaya Aleksandra A Feuer William W Ameri Hossein H Arevalo J Fernando JF Augustin Albert J AJ Birch David G DG Dagnelie Gislin G Grisanti Salvatore S Davis Janet L JL Hahn Paul P Handa James T JT Ho Allen C AC Huang Suber S SS Humayun Mark S MS Iezzi Raymond R Jayasundera K Thiran KT Kokame Gregg T GT Lam Byron L BL Lim Jennifer I JI Mandava Naresh N Montezuma Sandra R SR Olmos de Koo Lisa L Szurman Peter P Vajzovic Lejla L Wiedemann Peter P Weiland James J Yan Jiong J Zacks David N DN

American journal of ophthalmology 20180627

<h4>Purpose</h4>To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients.<h4>Design</h4>Prospective, noncomparative cohort study.<h4>Methods</h4>Setting: International multicenter study.<h4>Patients</h4>Argus II recipients enrolled in the Post-Market Surveillance Studies.<h4>Procedures</h4>Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thic ...[more]

PMID: 29940167

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Project description:Retinitis pigmentosa is a group of genetic disorders that involves the breakdown and loss of photoreceptors in the retina, resulting in progressive retinal degeneration and eventual blindness. The Argus II Retinal Prosthesis System is the only currently available surgical implantable device approved by Health Canada. It has been shown to improve visual function in patients with severe visual loss from advanced retinitis pigmentosa. The objective of this analysis was to examine the clinical effectiveness, cost-effectiveness, budget impact, and safety of the Argus II system in improving visual function, as well as exploring patient experiences with the system.We performed a systematic search of the literature for studies examining the effects of the Argus II retinal prosthesis system in patients with advanced retinitis pigmentosa, and appraised the evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria, focusing on visual function, functional outcomes, quality of life, and adverse events. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care over a 10-year time horizon. We also conducted a 5-year budget impact analysis. We used a qualitative design and an interview methodology to examine patients' lived experience, and we used a modified grounded theory methodology to analyze information from interviews. Transcripts were coded, and themes were compared against one another.One multicentre international study and one single-centre study were included in the clinical review. In both studies, patients showed improved visual function with the Argus II system. However, the sight-threatening surgical complication rate was substantial. In the base-case analysis, the Argus II system was cost-effective compared with standard care only if willingness-to-pay was more than $207,616 per quality-adjusted life-year. The 5-year budget impact of funding the Argus II system ranged from $800,404 to $837,596. Retinitis pigmentosa significantly affects people's ability to navigate physical and virtual environments. Argus II was described as enabling the fundamental elements of sight. As such, it had a positive impact on quality of life for people with retinitis pigmentosa.Based on evidence of moderate quality, patients with advanced retinitis pigmentosa who were implanted with the Argus II retinal prosthesis system showed significant improvement in visual function, real-life functional outcomes, and quality of life, but there were complications associated with the surgery that could be managed through standard ophthalmologic treatments. The costs for the technology are high.

Dataset Information

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.

Publications

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.

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