Central Vision Loss From Macular DiseasesNCT06670989
Training to Modify Fixational Eye Movements for Optimizing Visual Performance in People With Central Vision Loss
A study testing Fixation training in people with Central Vision Loss From Macular Diseases, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Vision Loss From Macular Diseases
- What is being tested?
- Fixation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants with normal vision:
- age 18 or above
- best corrected visual acuity of at least 20/20 in each eye
- cataracts, if present, must be minimal (grade 1 or below according to the Lens Opacity Classification System)
- normal contrast sensitivity for their ages
- stereoacuity at least 40 seconds of arc
Show all 13Show fewer
- no history or signs of any retinal diseases
- Participants with macular disorders:
- age 18 or above
- macular disorder present in both eyes
- presence of at least one scotoma within the central 5 degrees of the visual field and with best corrected visual acuity of at least 20/400 in the better-seeing eye
- no foveal island of vision left (i.e. absolute scotoma must include the foveal area)
- cataracts, if present, must be grade 2 or lower according to the Lens Opacity Classification System II
Who cannot join
- Participants with normal vision:
- younger than 18 years of age
- best corrected visual acuity worse than 20/20 in each eye
- cataracts worse than grade 1 according to the Lens Opacity Classification System II
- abnormal contrast sensitivity for their ages
- stereoacuity worse than 40 seconds of arc
Show all 14Show fewer
- history or signs of any retinal diseases
- Participants with macular disorders:
- younger than 18 years of age
- macular disorder absent in at least one eye
- no scotoma within the central 5 degrees of the visual field in the better-seeing eye
- best corrected visual acuity of worse than 20/400 in the better-seeing eye
- foveal island of vision
- cataracts worse than grade 2 according to the Lens Opacity Classification System II
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Wertheim School of Optometry & Vision Science, University of California Berkeley
Berkeley, California, 94720
About this study
Official title: Training to Modify Fixational Eye Movements for Optimizing Visual Performance
People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Central vision loss primarily results from eye diseases or disorders that affect the macular region of the retina, such as age-related macular degeneration (AMD) and Stargardt disease. The clinical wisdom is that exaggerated fixational eye movements are detrimental to vision. This forms the basis of the increasing number of clinical trials that use fixation stability (variability of eye positions during fixation) as an outcome measure to evaluate the effectiveness of interventions on age-related macular degeneration or other retinal diseases, despite the lack of causal evidence supporting or refuting a relationship between fixational eye movements and functional vision. If excessive fixational eye movements are indeed detrimental to vision for people with central vision loss, can we reduce the amount of their fixational eye movements, thus improve their fixation stability? And if so, does that lead to improved functional vision? The goal of this study is to examine the hypothesis that retinal image motion due to abnormal fixational eye movements can be modified through fixation training, with accompanied improvements in functional vision as a result.
- Being tested
- Fixation training
- Keywords
- fixational eye movements, microsaccades, saccade adaptation, fixation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixation trainingBehavioural
Training (adapting) microsaccades during fixation
| Study group | Role | What they receive |
|---|---|---|
| Microsaccade adaptation | Experimental | A fixation target will be presented at the center of the display and participants will be asked to keep the target visible at all time. The investigators will measure participants' fixational eye movements continuously and when a microsaccade (small fast eye movements that occur during fixation of a visual target) is detected, the fixation target (a small dot) will jump to a different location, depending on whether the training is to adapt the microsaccades to have smaller or larger amplitudes. With trials, participants would automatically correct for the spatial errors and thus adapting their microsaccade amplitudes. Training consists of 5-6 sessions of training (about 1 hour each). These training sessions will be scheduled weekly if possible, but it is alright if the sessions are not exactly weekly. Receives: Behavioral: Fixation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation stability
Eye positions measured while participants looked at a stationary fixation target for 10 seconds, quantified as the area that captures 68% of eye positions (unit: deg^2).
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Secondary outcomes (8)
Visual acuity
Smallest letter that can be read on an acuity chart (Bailey-Lovie acuity chart). Unit of measurement will be in the logarithm of the minimum angle of resolution (logMAR).
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Contrast sensitivity
The faintest (lowest contrast) letter that can be read using the Mars Contrast Sensitivity Test. Unit of measurement will be in the logarithm of the contrast sensitivity ("log units").
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Reading performance: Maximum reading speed
Maximum reading speed (unit: words per minute) measured using the MNREAD Acuity Chart (MNREAD Acuity Chart is the name of the instrument that will be used).
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Reading performance: critical print size
The smallest print size (unit: logMAR) on the MNREAD Acuity Chart that still allow participants to read at their maximum reading speed.
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Orientation judgement accuracy: low spatial-frequency
Accuracy for judging the orientation (tilted to the left or right) of a low spatial-frequency grating. Unit of measurement will be in proportion-correct.
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Orientation judgement accuracy: high spatial-frequency
Accuracy for judging the orientation (tilted to the left or right) of a high spatial-frequency grating. Unit of measurement will be in proportion-correct.
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Characteristics of fixational eye movements: microsaccade rate
Fixational eye movements during the 10 seconds when participants are asked to fixate a target for fixation stability measurement (primary measurement) will be analyzed. The rate of microsaccades (fast eye movements during fixation) will be measured (unit: number per second).
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Characteristics of fixational eye movements: microsaccade amplitude
Fixational eye movements during the 10 seconds when participants are asked to fixate a target for fixation stability measurement (primary measurement) will be analyzed. The amplitude of microsaccades (fast eye movements during fixation) will be measured (unit: degrees).
Measured: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Jun 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Vision Loss From Macular DiseasesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Susana Chung, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670989
- Sponsor's protocol ID
- R21EY030253
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will report summary results for the group. Some of the outcome measures are health related and we would like to protect the participants' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training to Modify Fixational Eye Movements for Optimizing Visual Performance
- ClinicalTrials.gov ID
- NCT06670989
- Acronym / sponsor ID
- R21EY030253
- Keywords
- fixational eye movements, microsaccades, saccade adaptation, fixation training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Nov 2024 (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.
People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Central vision loss primarily results from eye diseases or disorders that affect the macular region of the retina, such as age-related macular degeneration (AMD) and Stargardt disease. The clinical wisdom is that exaggerated fixational eye movements are detrimental to vision. This forms the basis of the increasing number of clinical trials that use fixation stability (variability of eye positions during fixation) as an outcome measure to evaluate the effectiveness of interventions on age-related macular degeneration or other retinal diseases, despite the lack of causal evidence supporting or refuting a relationship between fixational eye movements and functional vision. If excessive fixational eye movements are indeed detrimental to vision for people with central vision loss, can we reduce the amount of their fixational eye movements, thus improve their fixation stability? And if so, does that lead to improved functional vision? The goal of this study is to examine the hypothesis that retinal image motion due to abnormal fixational eye movements can be modified through fixation training, with accompanied improvements in functional vision as a result.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microsaccade adaptation | Experimental | Behavioral: Fixation trainingA fixation target will be presented at the center of the display and participants will be asked to keep the target visible at all time. The investigators will measure participants' fixational eye movements continuously and when a microsaccade (small fast eye movements that occur during fixation of a visual target) is detected, the fixation target (a small dot) will jump to a different location, depending on whether the training is to adapt the microsaccades to have smaller or larger amplitudes. With trials, participants would automatically correct for the spatial errors and thus adapting their microsaccade amplitudes. Training consists of 5-6 sessions of training (about 1 hour each). These training sessions will be scheduled weekly if possible, but it is alright if the sessions are not exactly weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age 18 or above
- best corrected visual acuity of at least 20/20 in each eye
- cataracts, if present, must be minimal (grade 1 or below according to the Lens Opacity Classification System)
- normal contrast sensitivity for their ages
- stereoacuity at least 40 seconds of arc
Key exclusion criteria (14 listed)
- younger than 18 years of age
- best corrected visual acuity worse than 20/20 in each eye
- cataracts worse than grade 1 according to the Lens Opacity Classification System II
- abnormal contrast sensitivity for their ages
- stereoacuity worse than 40 seconds of arc
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 |
|---|---|---|
| Fixation trainingTraining (adapting) microsaccades during fixation | Behavioural | Microsaccade adaptation |
Primary outcome
Fixation stability
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Eye positions measured while participants looked at a stationary fixation target for 10 seconds, quantified as the area that captures 68% of eye positions (unit: deg^2).
8 secondary outcomes
Visual acuity
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Contrast sensitivity
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Reading performance: Maximum reading speed
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Reading performance: critical print size
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Orientation judgement accuracy: low spatial-frequency
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Orientation judgement accuracy: high spatial-frequency
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Characteristics of fixational eye movements: microsaccade rate
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Characteristics of fixational eye movements: microsaccade amplitude
Time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No. We will report summary results for the group. Some of the outcome measures are health related and we would like to protect the participants' privacy.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixation training in people with Central Vision Loss From Macular Diseases, run by National Eye Institute (NEI) at 1 site in United States.
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 13 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fixation stability (time frame: Data will be collected immediately before (within 1 hour) the first training session and immediately after (within 1 hour) the last training session. Data will be reported when analysis is completed for all participants (target date: by June 2025).). 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 1 Nov 2024.