Recruiting

Eye Movement Rehabilitation

Sponsor:

Northeastern University

Code:

NCT04929756

Conditions

Low Vision

Age Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Interventions

Visual Feedback

Study Details

Brief summary:

Approximately 217 million people worldwide currently suffer from low vision, which impacts a broad range of activities of daily living and is associated with depression and increased mortality. Over half of the patients presenting for low vision services have eye disease that affects the fovea and surrounding macula and leads to central vision loss (CVL). People with CVL are forced to use eccentric vision as a substitute for their impaired fovea, however eye movement control and visual function is impaired with eccentric vision.

Recent evidence and preliminary results from the investigators show that rehabilitation methods can help improve oculomotor control and this can lead to improved functional outcomes. The investigators have developed new feedback-based training methods that aim to improve eccentric vision use by patients with CVL. In a series of studies, the investigators examine rehabilitation of fixation control, smooth pursuit eye movements that track moving objects and saccadic eye movements that abruptly change the point of regard. The investigators examine how visual feedback, scotoma awareness methods and hand-eye coordination can improve eccentric vision use. Improvements in oculomotor control are quantified with eye tracking methods and associated changes in visual function are quantified with acuity, contrast sensitivity and reading performance.

The proposed research therefore develops and translates state-of-the-art methods in basic science to clinical applications. Accomplishing the proposed aims will provide new and improved methods for rehabilitation strategies for visual impairment. The ultimate goal of this proposal is to maximize the residual visual function of people with low vision and to help them to live independently, thereby improving quality of life and minimizing the economic and social burden of visual impairment.

Conditions

Low Vision

Age Related Macular Degeneration

Study ID

NCT04929756

Start date

Sep 4, 2020

Status verified date

May, 2023

Completion date

Jan 31, 2024

Anticipated

Primary completion date

May 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • over 14 year of age
  • logMAR Acuity 0.5-1.0
  • Bi-lateral foveal scotomas < 7 °radius
  • Mini Mental State questionnaire ≥ 29
  • no history of concurrent peripheral vision loss

Exclusion Criteria:

-

Study Design

Enrollment

106 participants

Anticipated

Interventions and Outcome Measures

Arms

Fixation PRL

Visual feedback will be provided at the the preferred retinal locus (PRL) to train subjects to attend to a fixation location. Feedback consists of a gaze-contingent ring whose size varies depending on task performance. Training consists of 5 blocks of up to 50 trials, each block lasting approximately 10 minutes. Acuity and contrast sensitivity will be assessed at the PRL with forced choice psychophysical letter identification tasks. Gaze behavior will be measured with an eye tracker.

Smooth Pursuit PRL

Visual feedback will be provided to train subjects to attend to a PRL for smooth pursuit eye movements. Feedback consists of a gaze-contingent ring whose size varies depending on the subject's ability to center the ring on a drifting target. Training consists of 5 blocks of up to 50 trials, each block lasting approximately 10 minutes. Acuity and contrast sensitivity will be assessed at the PRL with forced choice psychophysical letter identification tasks. Smooth pursuit tracking behavior will be measured with an eye tracker.

Saccade PRL

Visual feedback will be provided to train subjects to attend to a PRL for saccadic eye movements. Feedback consists of a gaze-contingent ring whose size varies depending on the subject's ability to center the ring on an abruptly shifting dot. Training consists of 5 blocks of up to 50 trials, each block lasting approximately 10 minutes. Acuity and contrast sensitivity will be assessed at the PRL with forced choice psychophysical letter identification tasks. Saccadic eye movement behavior will be measured with an eye tracker.

Scotoma Awareness PRL

Subjects are often unaware of their scotomas because they are filled in with the surrounding background texture. The investigators will exploit this filling in to increase awareness of the scotoma by surrounding the scotoma with a visible disk that will be perceptually completed across the scotoma, rendering the scotoma visible. In a randomized within-subjects design, Acuity and contrast sensitivity will be assessed with and without a Scotoma Awareness Disk at a Fixation, Smooth Pursuit and Saccade PRL with forced choice psychophysical letter identification tasks. Oculomotor behavior will be measured with an eye tracker.

Meta-Guidance PRL

Oculomotor control can be promoted in the location around our hands. The investigators will exploit this meta-guidance advantage by asking subjects to move their hand and their PRL to an on-screen target. In a randomized within-subjects design, Acuity and contrast sensitivity will be assessed with and without a Hand Movement at a Fixation, Smooth Pursuit and Saccade PRL with forced choice psychophysical letter identification tasks. Oculomotor behavior will be measured with an eye tracker.

Interventions

Visual Feedback

Gaze-contingent visual feedback

Primary outcome measure

  • Change in Visual Acuity [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Contrast Sensitivity [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Fixation control [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Saccadic Eye Movement Latency [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Saccadic Eye Movement Amplitude [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Smooth Pursuit Eye Movement Latency [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]
  • Change in Smooth Pursuit Eye Movement Gain [ Time Frame: Before, immediately after and 2 weeks after behavioral intervention ]

Central Contacts and Locations

Central contacts

Locations

NECO Center for Eye Care

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nicole C Ross, O.D.

617-262-2020rossn@neco.edu

Cecilia Idman-Rait, BS

617-587-5686idmanraitc@neco.edu

More Information

Sponsor

Northeastern University

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northeastern University on 2023-05-06.