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Translation of Eye Movement Reading Training to Clinical Practice

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01853930
First received: May 2, 2013
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Macular Disease
Behavioral: PAECT (Platform for Administering Eye movement Control Training).
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translation of Eye Movement Reading Training to Clinical Practice

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change in reading performance and accuracy using MNREAD and VIEWSENTANCES test [ Time Frame: The investigators will be measuring change from 1,2 and 6 months. ] [ Designated as safety issue: No ]
    Patients 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 and the VIEWSENTANCES test.


Estimated Enrollment: 70
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laboratory training
Patients will be trained in the laboratory by a rehabilitation therapist
Behavioral: PAECT (Platform for Administering Eye movement Control Training).
The PAECT meta program will incorporate all of the exercises that we 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.
Home-based training
Patients will self instruct using the computer-based training with remote intervention by a therapist
Behavioral: PAECT (Platform for Administering Eye movement Control Training).
The PAECT meta program will incorporate all of the exercises that we 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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 microperimeter.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853930

Contacts
Contact: Janet P Szlyk, PhD (312) 996-1466 janeszly@uic.edu
Contact: William Seiple, PhD (917) 992-3521 WSeiple@lighthouse.org

Locations
United States, Illinois
Jesse Brown VAMC (WestSide Division) Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen M Lenehan    312-569-6343    Karen.Lenehan@va.gov   
Contact: Israel Rubinstein, MD    (312) 569-6129    Israel.Rubinstein@va.gov   
Principal Investigator: Janet P Szlyk, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Janet P Szlyk, PhD Jesse Brown VAMC (WestSide Division)
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01853930     History of Changes
Other Study ID Numbers: C0849-R
Study First Received: May 2, 2013
Last Updated: November 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
reading rehabilitation
macular degeneration
eccentric viewing

ClinicalTrials.gov processed this record on November 25, 2014