Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus

NCT05637385 | Unknown

• 1 other identifier: 2022P002309
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

When high-detail vision is lost due to a retinal disease such as macular degeneration, people see poorly, and have difficulty with eye movements (oculo-motor control). This preliminary study will investigate a potential behavioral intervention that may improve the ability to perform vision-related daily activities such as reading, recognising faces and watching television. The intervention involves many sessions that will train visual perception and eye movements over a period of a few months. Participants will have either lost central vision in both eyes or have normal vision (control group).

Conditions

Central Visual Impairment

Outcome Measures

Primary Outcomes (6)

• reading speed following eight training sessions

  reading of paragraphs of text

  comparing reading speed before intervention and after 8 sessions of training

• reading speed following sixteen training sessions

  reading of paragraphs of text

  comparing reading speed before intervention and after 16 sessions of training

• face discrimination threshold following eight training sessions

  recognizing differences between faces

  comparing face discrimination thresholds before intervention and after 8 sessions of training

• face discrimination threshold following sixteen training sessions

  recognizing differences between faces

  comparing face discrimination thresholds before intervention and after 16 sessions of training

• video comprehension (shared word score) following eight training sessions

  understanding and describing the content of short video clips

  comparing shared word scores before intervention and after 8 sessions of training

• video comprehension (shared word score) following sixteen training sessions

  understanding and describing the content of short video clips

  comparing shared word scores before intervention and after 16 sessions of training

Secondary Outcomes (11)

• PRL location relative to the location before the intervention (training)

  location at each of the 16 training sessions as compared to the location before intervention

• Oculo-motor reference location relative to the location before the intervention (training)

  at each of the 16 training sessions as compared to the location before intervention

• saccade dynamics relative to the location before the intervention (training)

  at each of the 16 training sessions as compared to the location before intervention

• single-letter visual acuity following eight training sessions

  comparing visual acuity before intervention and after 8 sessions of training

• single-letter visual acuity following sixteen training sessions

  comparing visual acuity before intervention and after 16 sessions of training

Other Outcomes (4)

• enrollment rate

  duration of enrollment period

• retention rate

  duration of intervention period

• treatment fidelity

  duration of intervention period

Study Arms (2)

central vision loss

EXPERIMENTAL

will receive behavioral intervention

Behavioral: Training of perception and oculo-motor control

normal vision

ACTIVE COMPARATOR

using simulated central scotomas, will receive behavioral intervention

Behavioral: Training of perception and oculo-motor control

Interventions

Training of perception and oculo-motor control BEHAVIORAL

Behavioral training of eye movements and perception

central vision loss; normal vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral foveal loss that includes the fovea in each eye, as determined through retinal examination
• fluent in English
• Cognitive function MoCA (Montreal Cognitive Assessment) test \>20
• Binocular visual acuity 20/800 or better
• able to sit for at least an hour

You may not qualify if:

• speech impediment
• history of neurological or psychiatric disease
• inability to provide informed consent
• inability to follow instructions in English
• Normal Vision Control Group
• fluent in English
• Cognitive function MoCA (Montreal Cognitive Assessment) test \>25
• Binocular visual acuity 20/40 or better
• able to sit for at least an hour
• any ophthalmic disease that might impact on the conduct of the study, especially conditions that cause vision field loss
• speech impediment
• history of neurological or psychiatric disease
• inability to provide informed consent
• inability to follow instructions in English

Sponsors & Collaborators

• Russell L. Woods: lead
• Research to Prevent Blindness / Lions Club International Foundation: collaborator

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Russell L Woods, PhD

  Schepens Eye Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe E Roth, BME

CONTACT

617 912 2590; zroth@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Scientist

Model Details: Two-way mixed (one within, one between) factor study. Same training, applied to central vision loss group and normal vision control group viewing with simulated central scotomas.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 5, 2022
• Study Start: March 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 5, 2022

Record last verified: 2022-11