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Behavioural Intervention
Fixation Training for Macular Degeneration
N/A
Waitlist Available
Research Sponsored by National Eye Institute (NEI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with normal vision: age 18 or above, best corrected visual acuity of at least 20/20 in each eye, minimal cataracts (grade 1 or below), normal contrast sensitivity for their ages, stereoacuity at least 40 seconds of arc, 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 with best corrected visual acuity of at least 20/400 in the better-seeing eye, no foveal island of vision left, cataracts grade 2 or lower
Must not have
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, abnormal contrast sensitivity for their ages, stereoacuity worse than 40 seconds of arc, history or signs of any retinal diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study whether training to reduce excessive eye movements can lead to improved vision in people with central vision loss caused by eye diseases such as age-related macular degeneration (AMD) and St
Who is the study for?
This trial is for individuals with central vision loss, often due to conditions like age-related macular degeneration (AMD) or Stargardt disease. Participants should have abnormal fixational eye movements compared to those with normal vision.
What is being tested?
The study tests whether fixation training can reduce exaggerated fixational eye movements in people with central vision loss, potentially improving their visual performance and stability of gaze.
What are the potential side effects?
Since the intervention involves non-invasive fixation training exercises, side effects are minimal but may include eye strain or fatigue from the exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with normal vision, minimal cataracts, and no retinal diseases.
Select...
I am over 18, have a macular disorder in both eyes, with a vision of 20/400 or better in one eye, and minimal cataracts.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 with vision issues not corrected to 20/20, have mild cataracts or worse, poor contrast sensitivity, stereoacuity over 40 seconds of arc, or any retinal disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fixation stability
Secondary study objectives
Characteristics of fixational eye movements: microsaccade amplitude
Characteristics of fixational eye movements: microsaccade rate
Contrast sensitivity
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Microsaccade adaptationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
National Eye Institute (NEI)Lead Sponsor
556 Previous Clinical Trials
1,407,442 Total Patients Enrolled
79 Trials studying Macular Degeneration
72,672 Patients Enrolled for Macular Degeneration