Translation of Eye Movement Reading Training to Clinical Practice
Phase: NA
Conditions: Macular Disease
Sponsor: VA Office of Research and Development

 
Translation of Eye Movement Reading Training to 
Clinical Practice 
NCT01853930 
 
 
 
 
 
 
 
 
Document Date: 10/17/2018 

RESEARCH PROTOCOL NARRATIVE 
Project Title: Translation of Eye Movement Reading Training to Clinical Practice  
 
Problem Statement:  
Currently, AMD is among the top three leading causes of vision loss in veterans (Chomsky et al., 1995; 
Quillen & Henry, 2000). A recent survey found that 67% percent of individuals enrolled in low-vision 
rehabilitation programs had AMD (Owsley et al., 2009). Vision losses associated with this disease 
increase with age, and its impact on veterans’ health care will dramatically increase as the number of 
older individuals is expected to double in the next ten years. In the United States, cases of early AMD are 
expected to double from 9.1 million to 17.8 million by 2050 (Rein et al., 2009).  
 
The deficits in visual function as a result of diseases affecting the central retina, including AMD, 
are debilitating, as individuals lose their ability to carry out many of their daily activities that require 
resolving fine spatial details (Szlyk et al., 1997; 1998a; 2001a; 2001b; Ardickas et al., 2002; Stelmack et 
al., 2002). Often, individuals with poor central vision lose self-esteem and are subject to depression due 
to their inability to function normally in everyday life (Szlyk et al., 1998b; 2000a; Brody et al., 2001; 
Grant, Seiple & Szlyk, 2011).  
 
As central visual acuity becomes progressively worse, a parafoveal locus for fixation, or 
preferred retinal locus (PRL), may be chosen because it provides better vision than the diseased fovea 
(Timberlake et al., 1986, 2006; Fletcher et al., 1999; Crossland et al., 2005;). Although reading speeds 
using a PRL are typically slower than with foveal vision, there are reports that the visual function of 
patients with macular disease can benefit from rehabilitation training (Watson & Jose, 1976; Nilsson & 
Nilsson, 1986; Nilsson, 1990; Frennesson et al., 1995; Hall & Ciuffreda, 2001). Many of the vision 
rehabilitation programs for these patients focus on eccentric viewing training and the use of optical 
magnifying devices (Goodrich & Quillman, 1977; Quillman, 1980; Maplesden, 1984; Nilsson & Nilsson, 
1986; Nilsson, 1990; Frennesson et al., 1995; Nilsson et al., 1998, 2003). Such programs have individual 
exercises that explicitly and implicitly train visual skills with the goal of improving reading performance. 
Many of the published studies have reported increases in reading speeds as a result of training with low-
vision devices, as well as maintenance of these skills and continued device usage following training 
(Watson et al., 1997). A different approach to reading rehabilitation emphasizes the training of 
oculomotor control relative to a new extrafoveal fixation locus (Solan et al., 1995; Hall & Ciuffreda, 
2001; Contestabile et al., 2002; Seiple, Szlyk et al., 2005, 2011).  
 
Our previous studies have shown that training with oculomotor control exercises results in 
significantly faster reading speeds in patients with AMD. All of our past work was conducted under 
controlled laboratory conditions. In the proposed study, we will examine whether these training 
exercises are effective when practiced at home. Because of the extensive cost of clinical resources 
required for vision rehabilitation and the significant number of veterans in need of services, it is critical 
to determine whether the training program can be made less expensive, but as effective when the 
program is self-trained.  
 
 
 

Key Questions:  
The key question of this proposed research project is whether a series of eye movement training 
exercises that we have validated in our laboratory environment can be translated into a home-based 
training system.  
 
The primary question that this research is designed to answer is: Can a home-based eye 
movement training program be as effective as a clinically administered program? In order to answer this 
question, we will assess whether the opportunity for increased practice afforded by having the program 
available at home results in improved reading performance.  
 
Methods of Procedure: 
Our previous laboratory studies have demonstrated that eye movement control training significantly 
improves reading performance. In the proposed study, we will translate our methods into clinical 
practice with a large sample of patients with central vision loss.  
 
In Phase 1, we will develop a standardized, user-friendly, computer-based platform that will 
allow patients to easily self-administer training exercises. The software platform will be designed to 
automatically choose the appropriate exercises based on a patient’s previous performance, run the 
training exercise, and collect performance data into a universal patient data file. In Phase 2, the platform 
will be tested in two settings: in standard clinical rehabilitation practice and in the patient’s home. 
Reading outcomes in the two settings will be compared.  
 
Phase 1 – Development and Testing of the Platform for Administration of Eye Movement Control 
Training (PAECT)  
The PAECT will be developed to allow patients to easily self-administer the exercises. We will design the 
interface to be accessible to users with low vision. Large icons, touch-sensitive displays, and/or voice 
controls will be used. The interface will be built, tested, and improved over the first year of the project.  
 
Phase 2 – Clinic-Based Versus Home-Based Training  
In this phase, we will compare reading outcomes from training with PAECT in a low-vision clinic setting 
and with feedback on performance given by a rehabilitation therapist to training with the PAECT by the 
patients in their own homes. We have previously demonstrated in our laboratory experiments that eye 
movement training exercises increase reading speed, but we wish to know whether these findings can 
be extrapolated to clinical practice. The results of this study will allow us to quantify the role of direct 
support and feedback from the therapist during each session versus any advantages that may result 
from more frequent practice on the exercises afforded by having the equipment at home.  
 
Procedure  
On Day 1 of the study, all patients will undergo clinical assessments to measure change in reading speed 
(MNREAD). Near refraction will be measured and, based on this, a pair of single vision spectacles will be 
made for each subject for testing purposes. On Day 2, all patients will return to the clinic for baseline 
assessments detailed instructions on running the PAECT platform and training on Module 1 of the 
platform. For those patients assigned to the clinical arm of the study, appointments will be made to 

return at weekly intervals for two-hour PAECT training sessions. During these sessions, the subjects will 
run the PAECT program in the clinic, with feedback and encouragement given by the therapist.  
 
There will be a total of eight training sessions. For those patients assigned to the At-home arm, 
arrangements will be made to deliver and set up a computer in their home. These subjects will be 
instructed to practice with the PAECT program as often as possible, but at least two hours per week. 
Patients will receive weekly from calls from the Program Coordinator, who will answer technical 
questions and encourage frequent use of the program, but no feedback about performance will be 
given. All patients in both arms will return to the clinic after one month, and two months to undergo 
assessments of reading performance. Each subject will participate in the study for 12 weeks: 1 screening 
visit, 1 baseline testing visit, 4 weeks of training, Month 1 assessment visit, 4 weeks of additional 
training, and a final assessment visit.  
 
Patient Recruitment 
Veteran patients will be recruited from the eye clinics of the Jesse Brown VAMC, Veteran and Non-
Veteran patients from the University of Illinois at Chicago (UIC) Department of Ophthalmology and 
Visual Sciences, and Captain James A. Lovell Federal Health Care Center in North Chicago. We have 
ongoing collaborations with these sites and have successfully recruited from these centers for past 
studies. All potential patients will undergo a standard clinical examination at the recruitment sites to 
determine eligibility for the study.  
 
Both Veterans and Non-Veterans will be recruited for this study, with priority given to eligible 
Veterans. The strict inclusion criteria will require additional subjects (non-veterans) to also be included 
in recruitment. This will allow us to meet recruitment levels specified by our VA Merit Review Grant. 
Non-veterans will not have medical records at the VA but their data will be stored and protected in an 
approved off-site VA laboratory. All data will be stored in a locked cabinet in a locked room with only 
research personnel access.  
 
Inclusion Criteria  
Patients with a diagnosis of retinal disease affecting the central visual field (e.g., non-exudative “dry” 
AMD) and a central scotoma, with visual acuity of less than or equal to 20/70 and greater than or equal 
to 20/400 (in the test eye) will be included in the study. The presence of a central scotoma and eccentric 
viewing will be confirmed using an Opko OCT/SLO Microperimeter. Our intent is to include subjects 
based upon their functional characteristics (e.g., eccentric viewing).  
 
Exclusion Criteria  
Patients will be screened to exclude those with other major ophthalmologic or neurologic disease, 
choroidal neovascularization (“wet” AMD), moderate to severe media opacities, and cognitive 
impairment. Patients’ disease status will be monitored throughout the study. 
 
Research Design and Statistical Analysis Plan 
We will recruit eligible patients per year for each of the three years for Phase 2 of the 
study to be assigned randomly to the Laboratory Group, while others will be assigned to 
an At-home Training Group. Three assessments will be taken for each subject: at 

baseline, and after 1 and 2 months. To analyze the assessment data, we will utilize a 
two-way (group by time) repeated measures design. A major advantage of this design is 
subject homogeneity; that is, subject effects are reduced.