- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Nicole C Ross, OD
- Telefoonnummer: 6175875626
- E-mail: rossn@neco.edu
Studie Contact Back-up
- Naam: Cecilia Idman-Rait, MPH
- E-mail: idmanraitc@neco.edu
Studie Locaties
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02115
- Werving
- New England College of Optometry
-
Contact:
- Nicole C Ross, OD, MSc.
- Telefoonnummer: 617-587-5626
- E-mail: rossn@neco.edu
-
Contact:
- Cecilia Idman-Rait, MPH
- E-mail: idmanraitc@neco.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Saccadic Accuracy (Landing Error)
Tijdsspanne: 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 )
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Saccadic Latency
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 )
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Oogziekten
- Gezichtsstoornissen
- Sensatiestoornissen
- Ziekten van het netvlies
- Blindheid
- Retinale degeneratie
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Visie, laag
- Maculaire degeneratie
- Blindheid, Corticaal
- Therapeutica
- Mind-body therapieën
- Complementaire therapieën
- Gedragstherapie
- Psychotherapie
- Gedragsdisciplines en activiteiten
- Feedback, psychologisch
- Biofeedback, psychologie
Andere studie-ID-nummers
- Saccades 2.0
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .