CoChat
Sign Up
Cited by 199Neuroscience and Neural EngineeringRetinal Development and DisordersRetinal Diseases and Treatments

The DOI matches its Crossref record; 26 of the 27 references it cites were found in a registry or an index.

Interim results of a multicenter trial with the new electronic subretinal implant Alpha AMS in 15 Patients blind from inherited retinal degenerations.

Open access
Stingl, Katarina, Schippert, Ruth, Bartz-Schmidt, Karl U., Besch, Dorothea, Cottriall, Charles L., Edwards, Thomas L., Gekeler, Florian, Greppmaier, Udo, Kiel, Katja, Koitschev, Assen, Kühlewein, Laura, MacLaren, Robert E., Ramsden, James D., Roider, Johann, Rothermel, Albrecht, Sachs, Helmut, Schröder, Greta S., Tode, Jan, Troelenberg, Nicole, Zrenner, Eberhart·2017·Frontiers in Neuroscience
DOI 10.3389/fnins.2017.00445PMC PMC5572402
Open this paper in CoChat — free accountOpen PDF

Abstract

Purpose: We assessed the safety and efficacy of a technically advanced subretinal electronic implant, RETINA IMPLANT Alpha AMS, in end stage retinal degeneration in an interim analysis of two ongoing prospective clinical trials. Methods: The subretinal visual prosthesis RETINA IMPLANT Alpha AMS (Retina Implant AG, Reutlingen, Germany) was implanted in 15 blind patients with hereditary retinal degenerations at four study sites with a follow-up period of 12 months (www.clinicaltrials.gov NCT01024803 and NCT02720640). Functional outcome measures included 1) screen-based standardized 2- or 4-alternative forced-choice tests of light perception, light localization, grating detection (basic grating acuity (BaGA) test) and Landolt C-rings; 2) grey level discrimination; 3) performance during activities of daily living (ADL-table tasks). Results: Implant-mediated light perception was observed in 13/15 patients. During the observation period implant mediated localization of visual targets was possible in 13/15 patients. Correct grating detection was achieved for spatial frequencies of 0.1 cpd (cycles per degree) in 4/15; 0.33 cpd in 3/15; 0.66 cpd in 2/15; 1.0 cpd in 2/15 and 3.3 cpd in 1/15 patients. In two patients visual acuity assessed with Landolt C- rings was 20/546 and 20/1111. Of 6 possible grey levels on average 4.6 +/-0.8 (mean +/- SD, n=10) were discerned. Improvements (power ON vs. OFF) of ADL table tasks were measured in 13/15 patients. Overall, results were stable during the observation period. Serious adverse events were reported in 4 patients: 2 movements of the implant, readjusted in a second surgery; 4 conjunctival erosion/dehiscence, successfully treated; 1 pain event around the coil, successfully treated; 1 partial reduction of silicone oil tamponade leading to distorted vision (silicon oil successfully refilled). The majority of adverse events were transient and mostly of mild to moderate intensity. Conclusions: Psychophysical and subjective data show that RETINA IMPLANT Alpha AMS is reliable, well tolerated and can restore limited visual functions in blind patients with degenerations of the outer retina. Compared with the previous implant Alpha IMS, longevity of the new implant Alpha AMS has been considerably improved. Alpha AMS has meanwhile been certified as a commercially available medical device, reimbursed in Germany by the public health system.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.3389/fnins.2017.00445

Cites

26 of 26 references verified0 citation errors · 0 not checkable

Statistics

Figures

Figure 1 (A) Subretinal Implant RETINA IMPLANT Alpha AMS with (a): Polyimide foil and attached CMOS chip; (b): Sclera patch on ceramic chip; (c): Silicone cable; (d): Subdermal ceramic housing; (e): Return electrode. (B) View of silicone-power-cable routed on top of skull bone (below periost) and return electrode at temple area.
Figure 1 (A) Subretinal Implant RETINA IMPLANT Alpha AMS with (a): Polyimide foil and attached CMOS chip; (b): Sclera patch on ceramic chip; (c): Silicone cable; (d): Subdermal ceramic housing; (e): Return electrode. (B) View of silicone-power-cable routed on top of skull bone (below periost) and return electrode at temple area.CC BY · PubMed Central
Figure 2 Summary (mean + SD) of scores for the ADL tasks shapes (A–C) and table set-up (D–F) for all time points tested (month 1, 2, 3, 6, 9, 12) for the conditions implant ON vs. implant OFF. (A,D) show the scores for detection of the item on the table, (B,E) show the scores for the localization of the item and (C,F) show the scores for recognition of the item. The number of participants with available data is indicated below the x-axis for both implant ON/implant OFF. Significant differences as analyzed via the Wilcoxon test are shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. As data for one patient at month 1 and for another patient at month 12 was only available for the condition “implant ON,” these data were excluded from the Wilcoxon analysis, but included in the summary statistics (mean + SD).
Figure 2 Summary (mean + SD) of scores for the ADL tasks shapes (A–C) and table set-up (D–F) for all time points tested (month 1, 2, 3, 6, 9, 12) for the conditions implant ON vs. implant OFF. (A,D) show the scores for detection of the item on the table, (B,E) show the scores for the localization of the item and (C,F) show the scores for recognition of the item. The number of participants with available data is indicated below the x-axis for both implant ON/implant OFF. Significant differences as analyzed via the Wilcoxon test are shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. As data for one patient at month 1 and for another patient at month 12 was only available for the condition “implant ON,” these data were excluded from the Wilcoxon analysis, but included in the summary statistics (mean + SD).CC BY · PubMed Central
Figure 3 Shown are the percentages of patients passing the Eye-Hand Coordination test successfully at each time-point. Significant differences as analyzed via the 2-sided Fisher's exact test are shown in the figures with *p < 0.05 and **p < 0.01. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. Except for one patient at month 9, none of the patients was able to position the object correctly when the implant was switched OFF.
Figure 3 Shown are the percentages of patients passing the Eye-Hand Coordination test successfully at each time-point. Significant differences as analyzed via the 2-sided Fisher's exact test are shown in the figures with *p < 0.05 and **p < 0.01. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. Except for one patient at month 9, none of the patients was able to position the object correctly when the implant was switched OFF.CC BY · PubMed Central
Figure 4 Shown are the mean + SD of correctly distinguished gray levels out of 6 combinations tested. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. Significant differences as analyzed via the Wilcoxon test are shown in the figure with *p < 0.05 and **p < 0.01. As data of 2 patients at month 1 and 3 and of 1 patient at month 6 for was only available for the condition “implant ON,” these data were excluded from the Wilcoxon analysis, but included in the summary statistics (mean + SD).
Figure 4 Shown are the mean + SD of correctly distinguished gray levels out of 6 combinations tested. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. Significant differences as analyzed via the Wilcoxon test are shown in the figure with *p < 0.05 and **p < 0.01. As data of 2 patients at month 1 and 3 and of 1 patient at month 6 for was only available for the condition “implant ON,” these data were excluded from the Wilcoxon analysis, but included in the summary statistics (mean + SD).CC BY · PubMed Central
Figure 5 Shown are the percentages of patients passing the BaLM light perception test (A) and the BaLM light localization test (B) successfully at each time-point. Significant differences as analyzed via the 2-sided Fisher's exact test are shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF.
Figure 5 Shown are the percentages of patients passing the BaLM light perception test (A) and the BaLM light localization test (B) successfully at each time-point. Significant differences as analyzed via the 2-sided Fisher's exact test are shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF.CC BY · PubMed Central
Figure 6 (A) shows the percentages of patients passing the basic grating acuity test successfully at each time-point for the conditions implant ON and implant OFF with significant differences as analyzed via the 2-sided Fisher's exact test shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. (B) shows the data of patients in cycles per degree (cpd) with implant ON with the bottom white and top gray box representing the first and third quartile, and the band inside the box representing the median. The ends of the whiskers represent the minimum and maximum values. For failed tests, a value of “0 cpd” was noted. Please note the broken y-axis. The number of patients performing the test is indicated below the x-axis.
Figure 6 (A) shows the percentages of patients passing the basic grating acuity test successfully at each time-point for the conditions implant ON and implant OFF with significant differences as analyzed via the 2-sided Fisher's exact test shown in the figures with *p < 0.05, **p < 0.01, and ***p < 0.001. The number of patients performing the test is indicated below the x-axis for implant ON/implant OFF. (B) shows the data of patients in cycles per degree (cpd) with implant ON with the bottom white and top gray box representing the first and third quartile, and the band inside the box representing the median. The ends of the whiskers represent the minimum and maximum values. For failed tests, a value of “0 cpd” was noted. Please note the broken y-axis. The number of patients performing the test is indicated below the x-axis.CC BY · PubMed Central
Figure 7 Overview of data available at the time of this report for the time points studied with solid lines indicating available data, dotted lines indicating that no visit occurred despite implant working properly (RIAG-TU-18, month 6 and 9; RIAG-KI-04, month 6) and arrowheads indicating a functioning implant. The blunt ends indicate that the implant stopped functioning; a detailed explanation for implant failures is given in the text.
Figure 7 Overview of data available at the time of this report for the time points studied with solid lines indicating available data, dotted lines indicating that no visit occurred despite implant working properly (RIAG-TU-18, month 6 and 9; RIAG-KI-04, month 6) and arrowheads indicating a functioning implant. The blunt ends indicate that the implant stopped functioning; a detailed explanation for implant failures is given in the text.CC BY · PubMed Central

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 27 references

Research works printed but not linked: 2

  1. Kernstock, 2011, 3D-visualisation of power supply cable of subretinal electronic implants during eye movement. [Abstract], Invest. Ophthalmol. Vis. Sci., 52, 1341
  2. Sachs, 2010, Subretinal implant: the intraocular implantation technique, Nova Acta Leopoldina NF III, 379, 217

Cited by

Sorted by citations

Related

See all

Metadata

Authors
Stingl, K., Schippert, R., Bartz-Schmidt, K. U., Besch, D., Cottriall, C. L., Edwards, T. L., Gekeler, F., Greppmaier, U., Kiel, K., Koitschev, A., Kühlewein, L., MacLaren, R. E., Ramsden, J. D., Roider, J., Rothermel, A., Sachs, H., Schröder, G. S., Tode, J., Troelenberg, N., & Zrenner, E.
Affiliations
  • University of Tübingen (DE)
  • University of Oxford (GB)
  • Katharinenhospital (DE)
  • Städtisches Klinikum Dresden (DE)
  • Olgahospital (DE)
  • Christian-Albrechts-Universität zu Kiel (DE)
  • Universität Ulm (DE)
ORCID
Venue
Frontiers in Neuroscience
Publisher
Frontiers Media SA
Published
2017-08-23
Volume
11
Pages
445-445
ISSN
1662-453X (ISSN-L)
DOI
10.3389/fnins.2017.00445
PMC
PMC5572402
OpenAlex
W2748114767
Cited by
198
References
27
Citations by year
2026: 21 · 2025: 15 · 2024: 17 · 2023: 21 · 2022: 22 · 2021: 28 · 2020: 29 · 2019: 23 · 2018: 20 · 2017: 1
FWCI
9.76
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Frontiers in Neuroscience (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Minerva Access (University of Melbourne) (submittedVersion, cc-by)
  • Multimedialen Archiv und Publikationsserver der Christian-Albrechts-Universität zu Kiel (Christian-Albrechts-Universität zu Kiel) (submittedVersion, cc-by)
  • OPen Access Repositorium der Universität Ulm (OPARU) (Ulm University) (submittedVersion, cc-by)
  • Universität Ulm, Kommunikations- und Informationszentrum (kiz) (cc-by)
Funders
  • National Institute for Health and Care Research (II-C2-0713-20005)
  • University of Oxford
  • Bundesministerium für Bildung und Forschung (FKZ 01GQ1002, 01GQ1002)
  • Oxford University Hospitals NHS Foundation Trust
  • Invention for Innovation
Topics
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neural Engineering
  • Health Sciences › Medicine › Ophthalmology › Retinal Development and Disorders
  • Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
Keywords
inherited retinal degeneration, light perception, light localization, grating detection, Landolt C, activities of daily living, implant safety, conjunctival erosion, silicone oil tamponade

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review