Retinal Prostheses in the Medicare Population[Entered Retrospectively].

Project Summary Title and Description

Title
Retinal Prostheses in the Medicare Population[Entered Retrospectively].
Description
To determine the safety, efficacy, and evidence for halting disease progression for retinal prosthesis systems (RPSs) and the outcomes that are and could be assessed in future studies of these devices.
Attribution
N/A
Authors of Report
N/A
Methodology description
We searched Medline, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Library, PubMed (unprocessed records only), and gray literature sources, including conference proceedings from specialty societies, for studies of RPS devices published from January 1, 2000, through April 25, 2016.We performed redundant title and abstract screening with one reviewer’s selection required for full-text article retrieval. Dual independent review was performed on all full-text articles, with disagreements resolved by consensus. Data extraction was performed by a single reviewer and was fully verified by a second reviewer. Extracted data included study design, psychometric properties assessment methods based on the COSMIN checklist, patient blinding to experimental condition, outcome assessor blinding to experimental condition, experimental condition randomly presented, number of outcome assessors, country/site, number of patients enrolled, patient inclusion criteria, patient exclusion criteria, RPS treatment details, prior treatment, concurrent treatment, study duration, diagnosis, age at diagnosis, age at implantation, eye implanted, time from implantation to study participation, sex, race, visual acuity at time of implantation, outcomes, and outcome definitions. We assessed risk of bias of individual studies for the outcomes of interest, and graded the overall strength of evidence using Evidence-based Practice Centers guidance.
PROSPERO
N/A
DOI
10.26300/g3ed-hb35
Notes
Data entered retrospectively by uploading a file with both efficacy and adverse event outcomes.
Funding Source
AHRQ

Key Questions

1. KQ1A: What outcome measures have been used in studies of RPSs?
2. KQ1B: What are the psychometric properties of the health-related quality of life (HRQoL), ability to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs), visual function, and other measures used in the studies?
3. KQ1C: What other reliable and valid measures could be used in future studies of RPSs to demonstrate improvement in HRQoL, ability to perform ADLs and IADLs, visual function, and other functions?
4. KQ2: What is the evidence that HRQoL, ability to perform ADLs and IADLs, visual function, and other outcomes are improved in patients who use an RPS compared with baseline (or device OFF or untreated eye) and compared with alternative treatments?
5. KQ3: What is the evidence that the use of RPS arrests the progression of RP?
6. KQ4: What is the evidence on adverse events associated with the use of RPS?
7. KQ5A: What is the evidence on off-label use of RPS?
8. KQ5B: From a narrative review of the literature, are other uses suggested for RPS?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
FLORA: Phase I development of a functional vision assessment for prosthetic vision users.2015
Grating acuity and contrast tests for clinical trials of severe vision loss.2011
The artificial silicon retina in retinitis pigmentosa patients (an american ophthalmological association thesis).2010
Reliability and consistency of visual acuity and contrast sensitivity measures in advanced eye disease.2005
Developing the impact of vision impairment-very low vision (IVI-VLV) questionnaire as part of the LoVADA protocol.2014
Developing an instrumental activities of daily living tool as part of the low vision assessment of daily activities protocol.2014
Respondent impact on functional ability outcome measures in vision rehabilitation.2007
Full-field stimulus testing (FST) to quantify visual perception in severely blind candidates for treatment trials.2007
Reliability and consistency of dark-adapted psychophysical measures in advanced eye disease.2006
Evaluating psychometric properties of a clinical and a self-report blind rehabilitation outcome measure.2005
Measuring low-vision rehabilitation outcomes with the NEI VFQ-25.2002
Not Found - Please check PubMed ID for accuracy.-- Not Found --
The Argus II retinal prosthesis: surgical and functional outcomes in younger retinitis pigmentosa (RP) patients [poster PO267; slide set]. In: American Academy of Ophthalmology 2015 annual meeting;
Long‑term results from an epiretinal prosthesis to restore sight to the blind.2015
The use of Argus® II retinal prosthesis by blind subjects to achieve localisation and prehension of objects in 3-dimensional space.2015
Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis.2013
Interim results from the international trial of Second Sight's visual prosthesis.2012
Five-year data from the Argus II retinal prosthesis system clinical trial.2015
MRI brain scans in two patients with the argus II retinal prosthesis.2013
Reading visual braille with a retinal prosthesis.2012
The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss.2013
Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements.2012
An analysis of observer-rated functional vision in patients implanted with the Argus II Retinal Prosthesis System at three years.2016
Visual and non-visual navigation in blind patients with a retinal prosthesis.2015
Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.2016
Argus II retinal prosthesis malrotation and repositioning with intraoperative optical coherence tomography in a posterior staphyloma.2015
Subretinal Visual Implant Alpha IMS--Clinical trial interim report.2015
Safety and efficacy of subretinal visual implants in humans: methodological aspects.2013
First-in-human trial of a novel suprachoroidal retinal prosthesis.2014
The Argus II Retinal Prosthesis: 12-month outcomes from a single-study center.2014
Stimulation with a wireless intraocular epiretinal implant elicits visual percepts in blind humans.2011
Implantation and explantation of an active epiretinal visual prosthesis: 2-year follow-up data from the EPIRET3 prospective clinical trial.2012
Implantation and explantation of a wireless epiretinal retina implant device: observations during the EPIRET3 prospective clinical trial.2009
Angiographic findings following tack fixation of a wireless epiretinal retina implant device in blind RP patients.2011
Intraocular epiretinal prosthesis to restore vision in blind humans.2008
Subretinal electronic chips allow blind patients to read letters and combine them to words.2011
Orientation and mobility assessment in retinal prosthetic clinical trials.2012
The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa.2004
Ten-year Follow-Up of a Subretinal Silicon Prosthesis for Retinitis Pigmentosa.2015
The Argus II retinal prosthesis in RP patients: surgical and functional outcomes from the KKESH Collaborative Retina Study Group [slide presentation].

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