Central Visual ImpairmentNCT05637385
Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus
A study of Central Visual Impairment, run by Russell L. Woods.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Visual Impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- fluent in English
Show all 9Show fewer
- Cognitive function MoCA (Montreal Cognitive Assessment) test >25
- Binocular visual acuity 20/40 or better
- able to sit for at least an hour
Who cannot join
- speech impediment
- history of neurological or psychiatric disease
- inability to provide informed consent
- inability to follow instructions in English
- Normal Vision Control Group
- any ophthalmic disease that might impact on the conduct of the study, especially conditions that cause vision field loss
Show all 10Show fewer
- speech impediment
- history of neurological or psychiatric disease
- inability to provide informed consent
- inability to follow instructions in English
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the detailed description
The purpose of the study is evaluate a potential treatment for loss of (foveal) central vision in both eyes which results in the use of a preferred retinal locus (PRL). The treatment is a series of 16 sessions of about one-hour duration that will involve a mixture of oculomotor control (OMC) training, perceptual training, and scotoma awareness. Two groups will receive the training: (1) central vision loss; and (2) normal sight who will use a simulated scotoma (called control group below).
A single-site, two-way mixed factor, one within-subject and one between-subject, minimal-risk phase-2 study. Each participant with vision loss or in the control group will attend for three outcome-measurement visits and 16 training visits over a period of about two months (at 2 visits per week). Feasibility metrics will be obtained during recruitment and study conduct. PRL and OMC metrics will be obtained at every visit. Outcome metrics will be obtained before treatment, following 8 training sessions, and following 16 training sessions.
Participants in the control group will experience a simulated central scotoma created by a gaze-contingent visual display system that simulates the loss of central vision by obscuring a region of central vision during testing and training.
Participants will be trained using an integrated oculo-motor and perceptual training approach using a gaze-contingent visual display to provide scotoma awareness. Two tasks will alternate: (1) a textured search target that suddenly shifts, drifts smoothly, or is stable, requiring the subject to make a saccade, a smooth pursuit, or fixate, respectively, following which there is a same-different task to test attention; and (2) target following and visual search for (a) face within distractors, (b) object recognition and location, and (c) word recognition and object identification over cluttered background. During training, for the vision-loss group, the binocular scotoma (created by the retinal lesions) will be outlined using a gaze-contingent system, so that the subject will see a border at the edge of their binocular scotoma that moves with gaze, alerting them to the location of the scotoma.
In addition to the 16 training sessions, there will be longer (2.5 to 3 hours) measurement sessions: (1) before training; (2) after 8 training sessions; and (3) after 16 training sessions. Due to the number of procedures, the first measurement session might consist of two sessions. Thus, each participant with vision loss will participate in 19 or 20 sessions in total.
Ideally, participants will attend for two visits per week. However, the schedule is flexible and can be adapted to a participants schedule.
- Conditions
- Central Visual Impairment
- Being tested
- Training of perception and oculo-motor control
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of perception and oculo-motor controlBehavioural
Behavioral training of eye movements and perception
| Study group | Role | What they receive |
|---|---|---|
| central vision loss | Experimental | will receive behavioral intervention Receives: Behavioral: Training of perception and oculo-motor control |
| normal vision | Active comparator | using simulated central scotomas, will receive behavioral intervention Receives: Behavioral: Training of perception and oculo-motor control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reading speed following eight training sessions
reading of paragraphs of text
Measured: comparing reading speed before intervention and after 8 sessions of training
reading speed following sixteen training sessions
reading of paragraphs of text
Measured: comparing reading speed before intervention and after 16 sessions of training
face discrimination threshold following eight training sessions
recognizing differences between faces
Measured: comparing face discrimination thresholds before intervention and after 8 sessions of training
face discrimination threshold following sixteen training sessions
recognizing differences between faces
Measured: 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
Measured: 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
Measured: 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 of the preferred retinal locus measured from a retinal image obtained during a fixation examination
Measured: 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)
first landing location of saccades to a new location measured using a gaze tracking system; measures whether there has been an adjustment of eye movement planning
Measured: at each of the 16 training sessions as compared to the location before intervention
saccade dynamics relative to the location before the intervention (training)
slope of the saccadic main sequence, which is the speed to distance relationship of saccades (fast eye movements), as measured using a gaze tracking system
Measured: at each of the 16 training sessions as compared to the location before intervention
single-letter visual acuity following eight training sessions
ability to read single letters of varying size
Measured: comparing visual acuity before intervention and after 8 sessions of training
single-letter visual acuity following sixteen training sessions
ability to read single letters of varying size
Measured: comparing visual acuity before intervention and after 16 sessions of training
letter contrast sensitivity following eight training sessions
ability to read "large" letters of low contrast
Measured: comparing letter contrast sensitivity before intervention and after 8 sessions of training
letter contrast sensitivity following sixteen training sessions
ability to read "large" letters of low contrast
Measured: comparing letter contrast sensitivity before intervention and after 16 sessions of training
Geriatric Depression Scale (GDS) following eight training sessions
evaluate depression and aspects of quality of life
Measured: comparing GDS scores before intervention and after 8 sessions of training
Geriatric Depression Scale (GDS) following sixteen training sessions
evaluate depression and aspects of quality of life
Measured: comparing GDS scores before intervention and after 16 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions
measure of visual ability and vision-related limitations
Measured: comparing VA LV VFQ scores before intervention and after 8 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions
measure of visual ability and vision-related limitations
Measured: comparing VA LV VFQ scores before intervention and after 16 sessions of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russell L. Woods
- Sponsor type
- University, hospital or other
- Collaborators
- Research to Prevent Blindness / Lions Club International Foundation
- Responsible party
- Sponsor-investigator, Russell L. Woods, Schepens Eye Research Institute
- Investigators
- Russell L Woods, PhD, Principal investigator, Schepens Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637385
- Sponsor's protocol ID
- 2022P002309
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If approved by our IRB (Institutional Review Board), we may be able to share de-identified outcome metrics and eye movement measurements. A data use agreement would be required.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus
- ClinicalTrials.gov ID
- NCT05637385
- Acronym / sponsor ID
- 2022P002309
- Conditions
- Central Visual Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Russell L. WoodsUniversity, hospital or other
- Collaborators
- Research to Prevent Blindness / Lions Club International Foundation
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The purpose of the study is evaluate a potential treatment for loss of (foveal) central vision in both eyes which results in the use of a preferred retinal locus (PRL). The treatment is a series of 16 sessions of about one-hour duration that will involve a mixture of oculomotor control (OMC) training, perceptual training, and scotoma awareness. Two groups will receive the training: (1) central vision loss; and (2) normal sight who will use a simulated scotoma (called control group below).
A single-site, two-way mixed factor, one within-subject and one between-subject, minimal-risk phase-2 study. Each participant with vision loss or in the control group will attend for three outcome-measurement visits and 16 training visits over a period of about two months (at 2 visits per week). Feasibility metrics will be obtained during recruitment and study conduct. PRL and OMC metrics will be obtained at every visit. Outcome metrics will be obtained before treatment, following 8 training sessions, and following 16 training sessions.
Participants in the control group will experience a simulated central scotoma created by a gaze-contingent visual display system that simulates the loss of central vision by obscuring a region of central vision during testing and training.
Participants will be trained using an integrated oculo-motor and perceptual training approach using a gaze-contingent visual display to provide scotoma awareness. Two tasks will alternate: (1) a textured search target that suddenly shifts, drifts smoothly, or is stable, requiring the subject to make a saccade, a smooth pursuit, or fixate, respectively, following which there is a same-different task to test attention; and (2) target following and visual search for (a) face within distractors, (b) object recognition and location, and (c) word recognition and object identification over cluttered background. During training, for the vision-loss group, the binocular scotoma (created by the retinal lesions) will be outlined using a gaze-contingent system, so that the subject will see a border at the edge of their binocular scotoma that moves with gaze, alerting them to the location of the scotoma.
In addition to the 16 training sessions, there will be longer (2.5 to 3 hours) measurement sessions: (1) before training; (2) after 8 training sessions; and (3) after 16 training sessions. Due to the number of procedures, the first measurement session might consist of two sessions. Thus, each participant with vision loss will participate in 19 or 20 sessions in total.
Ideally, participants will attend for two visits per week. However, the schedule is flexible and can be adapted to a participants schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| central vision loss | Experimental | Behavioral: Training of perception and oculo-motor controlwill receive behavioral intervention |
| normal vision | Active comparator | Behavioral: Training of perception and oculo-motor controlusing simulated central scotomas, will receive behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- speech impediment
- history of neurological or psychiatric disease
- inability to provide informed consent
- inability to follow instructions in English
- Normal Vision Control Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training of perception and oculo-motor controlBehavioral training of eye movements and perception | Behavioural | central vision loss, normal vision |
Primary outcome
reading speed following eight training sessions
Time frame: comparing reading speed before intervention and after 8 sessions of training
reading of paragraphs of text
reading speed following sixteen training sessions
Time frame: comparing reading speed before intervention and after 16 sessions of training
reading of paragraphs of text
face discrimination threshold following eight training sessions
Time frame: comparing face discrimination thresholds before intervention and after 8 sessions of training
recognizing differences between faces
face discrimination threshold following sixteen training sessions
Time frame: comparing face discrimination thresholds before intervention and after 16 sessions of training
recognizing differences between faces
video comprehension (shared word score) following eight training sessions
Time frame: comparing shared word scores before intervention and after 8 sessions of training
understanding and describing the content of short video clips
video comprehension (shared word score) following sixteen training sessions
Time frame: comparing shared word scores before intervention and after 16 sessions of training
understanding and describing the content of short video clips
11 secondary outcomes
PRL location relative to the location before the intervention (training)
Time frame: 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)
Time frame: at each of the 16 training sessions as compared to the location before intervention
saccade dynamics relative to the location before the intervention (training)
Time frame: at each of the 16 training sessions as compared to the location before intervention
single-letter visual acuity following eight training sessions
Time frame: comparing visual acuity before intervention and after 8 sessions of training
single-letter visual acuity following sixteen training sessions
Time frame: comparing visual acuity before intervention and after 16 sessions of training
letter contrast sensitivity following eight training sessions
Time frame: comparing letter contrast sensitivity before intervention and after 8 sessions of training
letter contrast sensitivity following sixteen training sessions
Time frame: comparing letter contrast sensitivity before intervention and after 16 sessions of training
Geriatric Depression Scale (GDS) following eight training sessions
Time frame: comparing GDS scores before intervention and after 8 sessions of training
Geriatric Depression Scale (GDS) following sixteen training sessions
Time frame: comparing GDS scores before intervention and after 16 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions
Time frame: comparing VA LV VFQ scores before intervention and after 8 sessions of training
Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions
Time frame: comparing VA LV VFQ scores before intervention and after 16 sessions of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: Undecided. If approved by our IRB (Institutional Review Board), we may be able to share de-identified outcome metrics and eye movement measurements. A data use agreement would be required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell L Woods, PhD principal investigator
Schepens Eye Research Institute
Questions about this trial
What is this clinical trial studying?
A study of Central Visual Impairment, run by Russell L. Woods.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoe E Roth, BME (617 912 2590, zroth@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reading speed following eight training sessions (time frame: comparing reading speed before intervention and after 8 sessions of training). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.