Translation of Eye Movement Reading Training to Clinical Practice

NCT01853930 | Completed Results

• 1 other identifier: C0849-R
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Disease

Keywords

reading rehabilitation; macular degeneration; eccentric viewing

Outcome Measures

Primary Outcomes (1)

• Change in Reading Performance and Accuracy Using MNREAD.

  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.

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

Study Arms (2)

Laboratory training

OTHER

Patients will be trained in the laboratory with feedback by a rehabilitation therapist

Behavioral: Platform for Administering Eye-movement Control Training

Home-based training

OTHER

Patients will self instruct using the computer-based training with remote intervention by a therapist

Behavioral: Platform for Administering Eye-movement Control Training

Interventions

Platform for Administering Eye-movement Control Training BEHAVIORAL

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.

Home-based training; Laboratory training

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (6)

• Ming J, Thulborn KR, Szlyk JP. Reproducibility of activation maps for longitudinal studies of visual function by functional magnetic resonance imaging. Invest Ophthalmol Vis Sci. 2012 Sep 14;53(10):6153-63. doi: 10.1167/iovs.11-8375.

  PMID: 22879425 RESULT

• Grant P, Seiple W, Szlyk JP. Effect of depression on actual and perceived effects of reading rehabilitation for people with central vision loss. J Rehabil Res Dev. 2011;48(9):1101-8. doi: 10.1682/jrrd.2010.05.0080.

  PMID: 22234714 RESULT

• Seiple W, Grant P, Szlyk JP. Reading rehabilitation of individuals with AMD: relative effectiveness of training approaches. Invest Ophthalmol Vis Sci. 2011 May 5;52(6):2938-44. doi: 10.1167/iovs.10-6137.

  PMID: 21296824 RESULT

• Szlyk JP, Little DM. An FMRI study of word-level recognition and processing in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009 Sep;50(9):4487-95. doi: 10.1167/iovs.08-2258. Epub 2009 Apr 22.

  PMID: 19387076 RESULT

• Soong GP, Shapiro M, Seiple W, Szlyk JP. Macular structure and vision of patients with macular heterotopia secondary to retinopathy of prematurity. Retina. 2008 Oct;28(8):1111-6. doi: 10.1097/IAE.0b013e3181744136.

  PMID: 18779718 RESULT

• Little DM, Thulborn KR, Szlyk JP. An FMRI study of saccadic and smooth-pursuit eye movement control in patients with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2008 Apr;49(4):1728-35. doi: 10.1167/iovs.07-0372.

  PMID: 18385097 RESULT

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

Future research will address some of the limitations of this study such as greater diversity of subjects, a larger sample size and additional development and refinement of the program interface and user experience.

Results Point of Contact

• Title: Dr. Janet P. Szlyk, PhD
• Organization: Jesse Brown VA Medical Center

janet.szlyk@va.gov

312-997-3644

Study Officials

• Janet P Szlyk, PhD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 15, 2013
• Study Start: January 1, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 13, 2019
• Results First Posted: November 13, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)