Translation of Eye Movement Reading Training to Clinical Practice
Study Details
Study Description
Brief Summary
Age-related macular degeneration (AMD) is the most common visual impairment in persons over 50 years of age. It has been estimated that 1 in 3 individuals over 75 years of age and 1 in 30 individuals over 52 years of age are affected by AMD. The deficits in visual function as a result of this disease affecting the central retina are debilitating, as individuals lose their ability to carry out many of their daily activities that require resolving fine spatial details. The investigator's previous studies have shown that training with oculomotor control exercises significantly increases reading speeds in patients with AMD. In the proposed study, the investigators will examine whether these training exercises are effective when practiced at home.
In Phase 1, the investigators will develop a standardized user-friendly, Web-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. The investigators will recruit 60 patients per year for each of the three years for Phase 2 of the study. Half of these patients will be assigned to the Clinic Training Group, while the other half will be assigned to At-home Training Group. For all patients, three assessments will be taken: at baseline, after 1 month, and after 2 months of training.
The investigators will compare reading outcomes to assess the roles of feedback versus the role of frequent available practice. Because of the extensive cost and clinical resources required for vision rehabilitation, it is critical to determine whether the training program can be made less expensive, but as effective, when it is self-trained. If the investigators demonstrate the utility of at-home practice, clinical facilities and therapists' time can be made available for those activities requiring face-to-face contact
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In the proposed study, the investigators will examine whether these training exercises are effective when practiced at home. There are two specific aims in this project:
Aim #1 (Year 1): to develop a web-based meta program that will administer the training exercises. For convenience, in this proposal, the investigators will refer to this platform as PAECT (Platform for Administering Eye movement Control Training). The PAECT meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. The development of the software and the design of the hardware interface for administering the system will take place during the first year of the project. This will be done through a series of software/hardware iterations based upon feedback derived from direct patient testing of the system. The investigators will recruit ten patients with AMD to test and comment on the system during this phase of the project.
Aim #2 (Years 2-4). To compare the effects of PAECT training on reading outcomes in two training situations: (1). training done in the clinic with feedback on performance provided by a trained low-vision therapist, and (2) training done at-home with expanded opportunity for practicing the exercises, but with no therapist feedback. Patients will be assigned to one of two groups: Patients in Group 1 ("Clinical") will undergo weekly two-hour training sessions for three months using the software/hardware system. This training will be conducted in the low-vision clinic using the PAECT, with feedback on performance provided by a trained low-vision therapist. Patients in Group 2 ("At-home") will practice all of the exercises at home using the PAECT system over a three-month period. The subjects will be encouraged to use the system as often as possible, but no less than two hours per week. Sixty patients (30 in the clinical setting and 30 at home) will be tested for each of three years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Laboratory training Patients will be trained in the laboratory with feedback by a rehabilitation therapist |
Behavioral: Platform for Administering Eye-movement Control Training
The Platform for Administering Eye-movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance.
|
| Other: Home-based training Patients will self instruct using the computer-based training with remote intervention by a therapist |
Behavioral: Platform for Administering Eye-movement Control Training
The Platform for Administering Eye-movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance.
|
Outcome Measures
Primary Outcome Measures
- Change in Reading Performance and Accuracy Using MNREAD. [Participants will be assessed at baseline, 1 month and 2 months but change between baseline and final (2 months) will be reported]
Participants will be trained to use eccentric viewing for reading. They will then be assessed on the following outcome measures; reading, speed and accuracy using the MNRead test, binocular visual acuity and contrast sensitivity.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with a diagnosis of retinal disease affecting the central visual field (e.g., non-exudative "dry" AMD)
-
with a central scotoma
-
and 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 microperimetry.
-
The investigator's intent is to include subjects based upon the patient's functional characteristics (e.g., eccentric viewing).
Exclusion Criteria:
-
Patients with other major ophthalmologic or neurologic disease
-
choroidal neovascularization ("wet" AMD)
-
moderate to severe media opacities
-
and cognitive impairment will be excluded.
-
Patients' disease status will be monitored throughout the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Janet P Szlyk, PhD, Jesse Brown VA Medical Center, Chicago, IL
Study Documents (Full-Text)
More Information
Publications
None provided.- C0849-R
Study Results
Participant Flow
| Recruitment Details | 98 patients were screened for eligibility between January 2014 and June 2017 at the Jesse Brown VA Medical Center in Chicago, Illinois. |
|---|---|
| Pre-assignment Detail | 33 patients were assigned to either the laboratory training group or the home-based training group. 14 were assigned to the focus group during the developmental phase (year 1) of the web-based meta program and are not included in the analysis of outcome measures. 26 did not meet the inclusion criteria and 25 declined to participate. |
| Arm/Group Title | Laboratory Training | Home-based Training |
|---|---|---|
| Arm/Group Description | Patients will be trained in the laboratory by a rehabilitation therapist The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | Patients will self instruct using the computer-based training with remote intervention by a therapist as needed The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. |
| Period Title: Overall Study | ||
| STARTED | 25 | 8 |
| COMPLETED | 25 | 8 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Laboratory Training | Home-based Training | Total |
|---|---|---|---|
| Arm/Group Description | Patients will be trained in the laboratory by a rehabilitation therapist The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | Patients will self instruct using the computer-based training with remote intervention by a therapist as needed The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | Total of all reporting groups |
| Overall Participants | 25 | 8 | 33 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
11
44%
|
2
25%
|
13
39.4%
|
| >=65 years |
14
56%
|
6
75%
|
20
60.6%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.6
(24.1)
|
75.9
(11.9)
|
68.1
(22.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
64%
|
5
62.5%
|
21
63.6%
|
| Male |
9
36%
|
3
37.5%
|
12
36.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
8%
|
0
0%
|
2
6.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
16%
|
1
12.5%
|
5
15.2%
|
| White |
17
68%
|
7
87.5%
|
24
72.7%
|
| More than one race |
2
8%
|
0
0%
|
2
6.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
25
100%
|
8
100%
|
33
100%
|
| Reading Performance and Accuracy (Words Per Minute (WPM)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Words Per Minute (WPM)] |
60.4
(41.1)
|
40.9
(35.6)
|
55.7
(40.2)
|
| Visual Acuity (logMAR) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [logMAR] |
0.95
(0.23)
|
0.98
(0.27)
|
0.96
(0.24)
|
| Contrast (logCS) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [logCS] |
1.01
(0.43)
|
1.08
(0.41)
|
1.03
(0.42)
|
Outcome Measures
| Title | Change in Reading Performance and Accuracy Using MNREAD. |
|---|---|
| Description | Participants will be trained to use eccentric viewing for reading. They will then be assessed on the following outcome measures; reading, speed and accuracy using the MNRead test, binocular visual acuity and contrast sensitivity. |
| Time Frame | Participants will be assessed at baseline, 1 month and 2 months but change between baseline and final (2 months) will be reported |
Outcome Measure Data
| Analysis Population Description |
|---|
| All 33 participants who received and completed training on the PAECT platform for eight weeks (in the laboratory or at-home) were included in the analysis. |
| Arm/Group Title | Laboratory Training | Home-based Training |
|---|---|---|
| Arm/Group Description | Patients will be trained in the laboratory by a rehabilitation therapist The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | Patients will self instruct using the computer-based training with remote intervention by a therapist as needed The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. |
| Measure Participants | 25 | 8 |
| Mean (Standard Deviation) [Words Per Minuted (WPM)] |
22.59
(26.51)
|
24.68
(17.76)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Laboratory Training, Home-based Training |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option. | |
| Statistical Test of Hypothesis | p-Value | 0.876 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | t= -0.157 df= 30 | |
Adverse Events
| Time Frame | Participants were assessed at baseline, 1 month and 2 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Laboratory Training | Home-based Training | ||
| Arm/Group Description | Patients will be trained in the laboratory by a rehabilitation therapist The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | Patients will self instruct using the computer-based training with remote intervention by a therapist as needed The Platform for Administering Eye movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow future patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance. | ||
All Cause Mortality |
||||
| Laboratory Training | Home-based Training | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/8 (0%) | ||
Serious Adverse Events |
||||
| Laboratory Training | Home-based Training | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/8 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Laboratory Training | Home-based Training | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | 0/8 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Janet P. Szlyk, PhD |
|---|---|
| Organization | Jesse Brown VA Medical Center |
| Phone | 312-997-3644 |
| janet.szlyk@va.gov |
- C0849-R