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N/A N=33 Randomized Single-blind Treatment

Translation of Eye Movement Reading Training to Clinical Practice

Macular Disease

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Reading Performance and Accuracy Using MNREAD. — 22.59; 24.68 Words Per Minuted (WPM) — p=0.876

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Platform for Administering Eye-movement Control Training (Behavioral)
Age
Adult, Older Adult · 55+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Reading Performance and Accuracy Using MNREAD.
22.59; 24.68 0.876

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

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01853930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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