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Vision Rehabilitation Training With Multimodal Feedback in Central Vision Loss

5 de mayo de 2026 actualizado por: New England College of Optometry

Central vision loss from macular degeneration creates blind spots that impair reading, face recognition, and navigation. Individuals must learn to use peripheral vision, requiring retraining of eye movements. Our preliminary research using high-speed eye tracking demonstrated that people with larger scotomas have impaired eye movement control, and that single-session visual feedback training showed limited immediate benefit, though combining feedback types showed promise.

This study will evaluate whether extended binocular training (5 weekly sessions) with multimodal feedback improves eye movement control in 8-15 participants with bilateral central vision loss. Unlike conventional monocular rehabilitation systems, our approach trains both eyes simultaneously using real-time visual and auditory feedback during saccadic and smooth pursuit tasks. Participants will receive gaze-contingent scotoma awareness feedback, preferred retinal locus feedback, and auditory cues while performing eye tracking exercises.

Primary outcomes include saccadic accuracy (latency, landing error, amplitude) and smooth pursuit parameters (gain, tracking accuracy). Secondary outcomes include contrast sensitivity and self-reported visual function. Success could establish an evidence base for accessible home-based training using virtual reality technology, potentially benefiting millions with macular degeneration.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

12

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Nicole C Ross, OD
  • Número de teléfono: 6175875626
  • Correo electrónico: rossn@neco.edu

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Reclutamiento
        • New England College of Optometry
        • Contacto:
          • Nicole C Ross, OD, MSc.
          • Número de teléfono: 617-587-5626
          • Correo electrónico: rossn@neco.edu
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

Bilateral central scotomas confirmed via computerized tangent screen Visual acuity between 20/60 and 20/200 (0.5 - 1.00 logMAR) in either eye Stable central vision loss (no change in visual acuity >0.2 logMAR in past 6 months) Age 14 years or older, with diagnosis of macular disease Normal cognitive function (Mini-Mental State Examination score ≥24) Ability to provide informed consent and complete study visits No major hearing loss Fluent in English

Exclusion Criteria:

Unstable ocular disease (e.g., ongoing treatments and/or injections) Peripheral vision loss of less than 40 degrees Conditions affecting oculomotor control independent of CVL

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Feedback Training
All participants will receive binocular oculomotor training with multimodal feedback. Participants will complete 5 weekly training sessions (approximately 60 minutes each) performing saccadic and smooth pursuit eye movement exercises. Training incorporates three types of feedback presented systematically across sessions: (1) scotoma awareness feedback via gaze-contingent black circle overlay representing the blind spot, (2) preferred retinal locus (PRL) feedback via dynamic gaze-contingent ring showing real-time fixation location, and (3) auditory feedback with tone modulation indicating fixation stability, PRL accuracy, and target acquisition. Eye movements are recorded using binocular eye tracking at 2000Hz. Contrast sensitivity is assessed intermittently during training using adaptive Gabor presentations. Outcomes are measured at baseline (Week 0) and post-training (Week 6).

Participants will complete 5 weekly training sessions (approximately 60 minutes each) performing eye movement exercises while receiving real-time multimodal feedback. Training includes:

Saccadic Training: Visually-guided saccades to targets appearing at randomized locations with instructions to use peripheral (inferior) retinal locus. Targets shift horizontally, vertically, and obliquely to train all saccadic directions.

Smooth Pursuit Training: Circular pursuit of moving targets at 2.6°/s in randomized directions with instructions to maintain peripheral gaze above the target.

Feedback Modalities (systematically varied across sessions):Scotoma Awareness: Gaze-contingent black circle overlay representing participant's blind spot; Preferred Retinal Locus (PRL) Feedback: Dynamic gaze-contingent ring showing real-time fixation location; Auditory Feedback: Tone modulation indicating fixation stability, PRL accuracy, and target acquisition success; Combined multimodal feedback

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Saccadic Accuracy (Landing Error)
Periodo de tiempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Mean distance in degrees between saccade landing position and target location, measured using binocular eye tracking during visually-guided saccade tasks. Lower values indicate better accuracy.
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Saccadic Latency
Periodo de tiempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Time in milliseconds from target appearance to saccade initiation, measured using binocular eye tracking. Faster latencies indicate improved oculomotor response.
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Change in Smooth Pursuit Gain
Periodo de tiempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Ratio of eye velocity to target velocity during smooth pursuit tasks (optimal gain = 1.0). Higher gain values indicate better pursuit tracking accuracy.
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Change in Number of Catch-up Saccades During Pursuit
Periodo de tiempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Mean number of corrective saccades per trial during smooth pursuit tasks. Fewer catch-up saccades indicate smoother, more accurate pursuit performance.
At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
Change in Contrast Sensitivity Function
Periodo de tiempo: Baseline, Post-training (Week 6)
Area under the log contrast sensitivity function (AULCSF) measured using adaptive Gabor presentations during eye movement tasks. Higher values indicate better contrast sensitivity.
Baseline, Post-training (Week 6)
Change in Fixation Stability
Periodo de tiempo: Baseline, Post-training (Week 6)
Area of the bivariate contour ellipse at 95% confidence interval of fixation positions during stationary target fixation tasks, measured in square degrees. Smaller ellipse area indicates more stable fixation.
Baseline, Post-training (Week 6)
Change in Vision Related Quality of Life
Periodo de tiempo: At First study visit - Baseline, at last training session - week 5, and post training (week 11 )
Baseline, Post-training (Week 6)
At First study visit - Baseline, at last training session - week 5, and post training (week 11 )

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de enero de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

30 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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