CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Platform for Administering Eye-movement Control Trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01853930
NCT01853930N/ACompleted

Translation of Eye Movement Reading Training to Clinical Practice

VA Office of Research and Development·interventional·Posted May 15, 2013·Updated Nov 13, 2019

In Brief

A clinical study evaluating Platform for Administering Eye-movement Control Training for Macular Disease. Completed, enrolled 33 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJan 1, 2014
Primary CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 13.1 years ago

Interventions

Platform for Administering Eye-movement Control Trainingbehavioral

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.