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«Technology Assessment Retinal Prostheses in the Medicare Population Technology Assessment Program Draft May 18, 2016 Prepared for: Agency for ...»

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Technology Assessment

Retinal Prostheses in the

Medicare Population

Technology

Assessment Program

Draft

May 18, 2016

Prepared for:

Agency for Healthcare

Research and Quality

540 Gaither Road

Rockville, Maryland 20850

Retinal Prostheses in the Medicare Population

DRAFT Technology Assessment Report

Project ID: EYET1215

May 18, 2016

ii

Preface

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers

(EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The Centers for Medicare and Medicaid Services requested this report from the Evidence-based Practice Center (EPC) Program at the Agency for Healthcare Research and Quality (AHRQ). AHRQ assigned this report to the

following EPC: (To be inserted in final report) Evidence-based Practice Center (Contract Number:

HHSA290201500005I).

The reports and assessments provide organizations with comprehensive, evidence-based information on common medical conditions and new health care technologies and strategies. They also identify research gaps in the selected scientific area, identify methodological and scientific weaknesses, suggest research needs, and move the field forward through an unbiased, evidence-based assessment of the available literature. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments.

To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review and public comment prior to their release as a final report.

AHRQ expects that the EPC evidence reports and technology assessments, when appropriate, will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality.

If you have comments on this evidence report, they may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, MD 20857, or by email to epc@ahrq.hhs.gov Andrew Bindman, M.D. Arlene Bierma

–  –  –

iii This draft technology assessment is distributed solely for the purpose of public and peer review and/or discussion at the MedCAC meeting. It has not been otherwise disseminated by AHRQ. It does not represent and should not be construed to represent an AHRQ determination or policy.

This report is based on research conducted by the (name provided in final report) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No.

HHSA290201500005I). The findings and conclusions in this document are those of the authors who are responsible for its contents. The findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

None of the investigators has any affiliations or financial involvement related to the material presented in this report.

Persons using assistive technology may not be able to fully access information in this report. For assistance contact epc@ahrq.hhs.gov

–  –  –

Key Informants In designing the study questions, the Evidence-based Practice Center (EPC) consulted a panel of Key Informants who represent subject experts and end-users of research. Key Informant input can inform key issues related to the topic of the technical brief. Key Informants are not involved in the analysis of the evidence or the writing of the report. Therefore, in the end, study questions, design, methodological approaches and/or conclusions do not necessarily represent the views of individual Key Informants.

Key Informants must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their role as end-users, individuals with potential conflicts may be retained. The Task Order Officer and the EPC work to balance, manage, or mitigate any conflicts of interest.

The list of Key Informants who provided input to this report follows:

Key Informants To be added after peer review.

Peer Reviewers Prior to publication of the final evidence report, EPCs sought input from independent Peer Reviewers without financial conflicts of interest. However, the conclusions and synthesis of the scientific literature presented in this report does not necessarily represent the views of individual reviewers.

Peer Reviewers must disclose any financial conflicts of interest greater than $10,000 and any other relevant business or professional conflicts of interest. Because of their unique clinical or content expertise, individuals with potential non-financial conflicts may be retained. The Task Order Officer and the EPC work to balance, manage, or mitigate any potential non-financial conflicts of interest identified.





The list of Peer Reviewers will be added to the final report.

–  –  –

Structured Abstract Objectives. To determine the safety, efficacy and evidence of halting disease progression for retinal prosthesis systems (RPSs) and the outcomes that are and could be assessed in future studies of these devices.

Data sources. We searched MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Library, and 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 September 17, 2015.

Review methods. 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.

Results. Ten studies of RPS effectiveness were included. Although some patients clearly benefit from an RPS, the evidence was insufficient to estimate the proportion of patients who would benefit. Intraoperative adverse events were typically mild but some serious adverse events were reported, including intraocular pressure increase, hypotony, and presumed endophthalmitis. One study pointed to the possibility that RPSs may provide neuroprotection. Of the 73 outcomes reported in the 10 included studies, only 4 (Early Treatment of Diabetic Retinopathy Study test, Grating Acuity Test, Chow Color Test, and Functional Low-Vision Observer Rated Assessment) had evidence of validity and/or reliability. Measures with evidence of validity and reliability that could be used in future RPS studies include full-field flash test, Grating Contrast Sensitivity, FAST instrument (Functional Assessment of Self-Reliance on Tasks), Very Low Vision Instrumental Activities of Daily Living, Modified NEI-VFQ-25 plus supplement, and the Modified Impact of Vision Impairment Conclusions. Future studies of retinal prostheses devices should make an effort to report valid and reliable measures of day-to-day function and quality of life.

vi

Contents

Executive Summary

Introduction

Background

Retinitis Pigmentosa

Age-related Macular Degeneration

Retinal Prosthesis Systems

Alternative Treatments for Retinitis Pigmentosa and Age-Related Macular Degeneration... 7 Scope and Key Questions

Scope of the Review

Key Questions

Organization of This Report

Methods

Topic Refinement and Review Protocol

Literature Search Strategy

Search Strategy

Study Selection

Data Extraction

Risk-of-Bias Assessment of Individual Studies

Data Synthesis

Strength of the Body of Evidence

Applicability

Peer Review and Public Commentary

Results

Results of Literature Searches

Key Question 1A. Outcome Measures Used in RPS Studies

Description of Included Studies

Key Points

Detailed Synthesis

Key Question 1B. Psychometric Properties of Outcome Measures Used in RPS Studies....... 28 Description of Included Studies

Key Points

Description of Included Studies

Detailed Synthesis

Key Question 1C. Psychometric Properties of Other Possible Outcome Measures................. 30 Description of Included Studies

Key Points

Detailed Synthesis

Key Question 2. Effect of RPS on Health-related Quality of Life, Activities of Daily Living, Visual Function, and Other Outcomes

Description of Included Studies

Key Points

Detailed Synthesis

Key Question 3. RPSs to Arrest the Progression of Retinitis Pigmentosa

Description of Included Studies

Key Points

vii Detailed Synthesis

Key Question 4. Adverse Events of RPSs

Description of Included Studies

Key Points

Detailed Synthesis

Key Question 5A. Off-label use of RPSs

Description of Included Studies

Key Points

Detailed Synthesis

Key Question 5B. Other Uses of RPSs

Discussion

Key Findings and Strength of Evidence

Findings in Relationship to What is Already Known

Applicability

Implications for Clinical and Policy Decisionmaking

Limitations of the Systematic Review Process

Limitations of the Evidence Base

Evidence Gaps

Conclusion

References

Abbreviations and Acronyms

Tables Table 1. Retinal prosthesis system devices with published human studies

Table 2. PICOTS framework

Table 3. Evidence grade definitions

Table 4. Outcomes reported in included retinal prosthesis system studies

Table 5. Strength of evidence for effectiveness of retinal prosthesis systems for retinitis pigmentosa for each outcome

Figures Figure 1. Analytic framework

Figure 2. Study attrition diagram

Figure 3. Visual acuity: proportion of patients improved

Figure 4. Visual field: proportion of patients improved

Figure 5. Laboratory function: proportion of patients improved

Figure 6. Day-to-day function: proportion of patients improved

Appendixes Appendix A. Search Strategy Appendix B. Excluded Studies Appendix C. Evidence Tables viii Executive Summary Background Retinitis Pigmentosa Retinitis pigmentosa (RP) is a collection of genotypically and phenotypically diverse eye disorders, all of which attack the rods and cones within the retina or their adjacent support cells.

This inherited disease is often identified by its main clinical features, which typically include symptoms of poor night vision, visual field loss, and peripheral flickering lights. As the disease progresses and more photoreceptors are lost, patients experience an indolent, progressive constriction of their visual field until legal and functional blindness occurs, typically by age 40.1 Upon ophthalmic examination, a triad of clinical findings is typically noted: attenuation of retinal blood vessels, “bone spicule” clumping and mottling of the retinal pigment epithelium (a single layer of pigmented cells that nourishes the retina photoreceptors), and optic nerve head pallor.

All of these findings are a direct result of the main pathophysiologic action of RP, atrophy of the photoreceptor layer.

Age-related Macular Degeneration The RP population, particularly those with vision poor enough to qualify for a retinal prosthesis system (RPS), is rather small. The broader goal for most of the companies developing retinal prostheses would be for implementation in more common disease states. The most logical of these is late-stage nonexudative age-related macular degeneration (AMD), because many of the pathologic aspects of RP for RPS can also be found in AMD, namely physiologic damage limited to the outer retina. AMD is the leading cause of irreversible visual loss in industrialized countries.2 In the United States, it accounts for about half of severe sight loss. Although the etiology is incompletely understood, nonexudative AMD develops as a result of deposition of cellular debris—including lipids, amyloid, complement factors, and other components—in Bruch’s membrane.3,4 Retinal Prosthesis Systems Multiple types of ocular prosthetic devices are under development.5-9 The devices have focused on stimulating different parts of the visual pathway, including the visual cortex,7 the optic nerve,8 and the suprachoroidal,9 epiretinal,6 and subretinal5 spaces. Of the seven RPS devices for which there was at least one published article describing a study in humans, the only one to date to receive U.S. Food and Drug Administration (FDA) approval is the Argus II epiretinal RPS (Second Sight Medical Products, Inc., Sylmar, CA). Another device originating in the United States is the subretinal Artificial Silicon Retina (ASR), developed by Optobionics (Glen Ellyn, IL). The subretinal Alpha-IMS was created by Retina Implant AG (Reutlingen, Germany).



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