Trial Outcomes & Findings for Translation of Eye Movement Reading Training to Clinical Practice (NCT NCT01853930)

Last Updated: 2019-11-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Participants will be assessed at baseline, 1 month and 2 months but change between baseline and final (2 months) will be reported

Results posted on

2019-11-13

Participant Flow

98 patients were screened for eligibility between January 2014 and June 2017 at the Jesse Brown VA Medical Center in Chicago, Illinois.

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.

Participant milestones

Participant milestones
Measure	Laboratory Training 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.	Home-based Training 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.
Overall Study STARTED	25	8
Overall Study COMPLETED	25	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Translation of Eye Movement Reading Training to Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laboratory Training n=25 Participants 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.	Home-based Training n=8 Participants 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 n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	65.6 years STANDARD_DEVIATION 24.1 • n=5 Participants	75.9 years STANDARD_DEVIATION 11.9 • n=7 Participants	68.1 years STANDARD_DEVIATION 22.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants	8 Participants n=7 Participants	33 Participants n=5 Participants
Reading Performance and Accuracy	60.4 Words Per Minute (WPM) STANDARD_DEVIATION 41.1 • n=5 Participants	40.9 Words Per Minute (WPM) STANDARD_DEVIATION 35.6 • n=7 Participants	55.7 Words Per Minute (WPM) STANDARD_DEVIATION 40.2 • n=5 Participants
Visual Acuity	0.95 logMAR STANDARD_DEVIATION 0.23 • n=5 Participants	0.98 logMAR STANDARD_DEVIATION 0.27 • n=7 Participants	0.96 logMAR STANDARD_DEVIATION 0.24 • n=5 Participants
Contrast	1.01 logCS STANDARD_DEVIATION 0.43 • n=5 Participants	1.08 logCS STANDARD_DEVIATION 0.41 • n=7 Participants	1.03 logCS STANDARD_DEVIATION 0.42 • n=5 Participants

PRIMARY outcome

Timeframe: Participants will be assessed at baseline, 1 month and 2 months but change between baseline and final (2 months) will be reported

Population: 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.

Outcome measures

Outcome measures
Measure	Laboratory Training n=25 Participants 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.	Home-based Training n=8 Participants 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.
Change in Reading Performance and Accuracy Using MNREAD.	22.59 Words Per Minuted (WPM) Standard Deviation 26.51	24.68 Words Per Minuted (WPM) Standard Deviation 17.76

Adverse Events

Laboratory Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home-based Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Janet P. Szlyk, PhD

Jesse Brown VA Medical Center

Phone: 312-997-3644

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place