Retinal implants are being pursued by some 18 groups around the world, have been tested acutely by at least 5, and are being evaluated clinically by at least one consortium currently and by another 3 within the next year. Second Sight Medical Products (SSMP) has been developing tools to train and test implant recipients in its Argus"""""""" II trial, mostly in response to its own need and requirements by the FDA to quantify and document prosthesis function and patient performance. Some procedures were developed within SSMP, while others build on existing tests and training materials developed in low vision rehabilitation, in visual prosthesis trials, in pre-clinical visual prosthesis studies, and in prosthetic vision simulations. Yet, while building blocks of a future rehab curriculum do exist, no integrated approach to prosthetic low vision rehabilitation has been formulated. The immediate goal of the proposed program is to integrate, refine, and create tools for assessment and rehabilitation of ultra-low vision into a program that will provide research and clinical teams in the area of electronic visual prosthetics with the means to train, track, and evaluate implant patients, and collect the outcomes required to demonstrate functional effectiveness. The resulting ensemble of training and assessment tools, along with manuals and on-line course materials, will form a Prosthetic Low Vision Rehabilitation (PLoVR) curriculum. Specifically, we propose to 1. Expand the scale of visual tasks and abilities used in low vision rehabilitation towards ultra-low vision. A population of patients with extremely limited vision will create a """"""""bank"""""""" of activities, and be asked to rank these according to difficulty;a logit scale of item measures will be created through Rasch analysis. 2. Design and refine practice and assessment tools for minimally sighted individuals. We will create, and expand on, tools that stimulate and assess the use of vision (visual information gathering and of visually guided performance) and develop scoring systems and composite outcomes. 3. Evaluate the use of practice and assessment tools in patients with severe and profound vision loss. A group of ultra-low vision subjects will perform the tasks developed under Aim 2, for multiple parameter settings;Rasch analysis will be used to assign a difficulty score to each task and parameter setting.. 4. Validate the tools and scoring system in experienced and new retinal implant recipients. A group of 10 retinal implant wearers will practice and perform the same tasks;Rasch analysis will be used to examine potential differences between the two subject groups 5. Disseminate the PLoVR core curriculum: surveys, performance tasks, instructions and documentation We will create instruction manuals, an on-line course, and a user group for future PLoVR curriculum users. The PLoVR curriculum will be made available to research consortia pursuing treatment modalities for advanced eye disease, as a uniform set of standards to demonstrate clinical and functional effectiveness.

Public Health Relevance

Electronic implants to restore vision in patients blind from retinal disease are currently in early-stage clinical trials and may soon become available for wider clinical studies. Such implants will not provide good vision, but even minimal vision levels can make provide independence to patients who are now functionally blind. Very few tools are currently available to train patients in the use of vision at such very low levels, or to measure the effectiveness of these implants. The proposed study will develop such tools, and the instruction materials to train researchers and rehabilitation specialists in their use.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project (R01)
Project #
3R01EY021220-03S1
Application #
8714236
Study Section
Special Emphasis Panel (ZRG1-ETTN-E (92))
Program Officer
Wiggs, Cheri
Project Start
2011-01-01
Project End
2015-12-31
Budget Start
2013-01-01
Budget End
2013-12-31
Support Year
3
Fiscal Year
2013
Total Cost
$100,596
Indirect Cost
$38,500
Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Jeter, Pamela E; Rozanski, Collin; Massof, Robert et al. (2017) Development of the Ultra-Low Vision Visual Functioning Questionnaire (ULV-VFQ). Transl Vis Sci Technol 6:11
Adeyemo, Olukemi; Jeter, Pamela E; Rozanski, Collin et al. (2017) Living with Ultra-Low Vision: An Inventory of Self-Reported Visually Guided Activities by Individuals with Profound Visual Impairment. Transl Vis Sci Technol 6:10
Dagnelie, Gislin; Jeter, Pamela E; Adeyemo, Olukemi et al. (2017) Optimizing the ULV-VFQ for Clinical Use Through Item Set Reduction: Psychometric Properties and Trade-Offs. Transl Vis Sci Technol 6:12
Jeter, Pamela E; Haaz Moonaz, Steffany; Bittner, Ava K et al. (2015) Ashtanga-Based Yoga Therapy Increases the Sensory Contribution to Postural Stability in Visually-Impaired Persons at Risk for Falls as Measured by the Wii Balance Board: A Pilot Randomized Controlled Trial. PLoS One 10:e0129646
Geruschat, Duane R; Flax, Marshall; Tanna, Nilima et al. (2015) FLORA™: Phase I development of a functional vision assessment for prosthetic vision users. Clin Exp Optom 98:342-7
Jeter, Pamela E; Wang, Jiangxia; Gu, Jialiang et al. (2015) Intra-session test-retest reliability of magnitude and structure of center of pressure from the Nintendo Wii Balance Board™ for a visually impaired and normally sighted population. Gait Posture 41:482-7
Stronks, H Christiaan; Dagnelie, Gislin (2014) The functional performance of the Argus II retinal prosthesis. Expert Rev Med Devices 11:23-30
Stronks, H Christiaan; Barry, Michael P; Dagnelie, Gislin (2013) Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci 54:3891-901
Dagnelie, Gislin (2013) Age-related psychophysical changes and low vision. Invest Ophthalmol Vis Sci 54:ORSF88-93
Dorn, Jessy D; Ahuja, Ashish K; Caspi, Avi et al. (2013) The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol 131:183-9

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