- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07577219
Vision Rehabilitation Training With Multimodal Feedback in Central Vision Loss
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nicole C Ross, OD
- Numero di telefono: 6175875626
- Email: rossn@neco.edu
Backup dei contatti dello studio
- Nome: Cecilia Idman-Rait, MPH
- Email: idmanraitc@neco.edu
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Reclutamento
- New England College of Optometry
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Contatto:
- Nicole C Ross, OD, MSc.
- Numero di telefono: 617-587-5626
- Email: rossn@neco.edu
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Contatto:
- Cecilia Idman-Rait, MPH
- Email: idmanraitc@neco.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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).
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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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Saccadic Accuracy (Landing Error)
Lasso di tempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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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.
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At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Saccadic Latency
Lasso di tempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Time in milliseconds from target appearance to saccade initiation, measured using binocular eye tracking.
Faster latencies indicate improved oculomotor response.
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At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Change in Smooth Pursuit Gain
Lasso di tempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Ratio of eye velocity to target velocity during smooth pursuit tasks (optimal gain = 1.0).
Higher gain values indicate better pursuit tracking accuracy.
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At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Change in Number of Catch-up Saccades During Pursuit
Lasso di tempo: At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Mean number of corrective saccades per trial during smooth pursuit tasks.
Fewer catch-up saccades indicate smoother, more accurate pursuit performance.
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At First study visit - Baseline, At each training visit (week 1, week 2, week 3, week 4, week 5, and post training (week 11 )
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Change in Contrast Sensitivity Function
Lasso di tempo: Baseline, Post-training (Week 6)
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Area under the log contrast sensitivity function (AULCSF) measured using adaptive Gabor presentations during eye movement tasks.
Higher values indicate better contrast sensitivity.
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Baseline, Post-training (Week 6)
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Change in Fixation Stability
Lasso di tempo: Baseline, Post-training (Week 6)
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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.
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Baseline, Post-training (Week 6)
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Change in Vision Related Quality of Life
Lasso di tempo: At First study visit - Baseline, at last training session - week 5, and post training (week 11 )
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Baseline, Post-training (Week 6)
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At First study visit - Baseline, at last training session - week 5, and post training (week 11 )
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Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie degli occhi
- Disturbi della vista
- Disturbi della sensibilità
- Malattie retiniche
- Cecità
- Degenerazione retinica
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Visione, Bassa
- Degenerazione maculare
- Cecità, corticale
- Terapie
- Terapie mind-body
- Terapie complementari
- Terapia comportamentale
- Psicoterapia
- Discipline e attività comportamentali
- Feedback, psicologico
- Biofeedback, psicologia
Altri numeri di identificazione dello studio
- Saccades 2.0
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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