Factors in Learning And Plasticity: Macular Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham
About this trial
A greater understanding of plasticity after central vision loss can inform new therapies for treating low vision and has the potential to benefit millions of individuals suffering from low vision. The treatment of low vision is particularly relevant to the mission of the NEI to support research on visual disorders, mechanisms of visual function, and preservation of sight. The comparison of different training and outcome factors is in line with the NIMH RDOC framework and studies in an aging population are consistent with the mission of the NIA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-89
Severely impaired vision in both eyes (20/100 or worse)
diagnosis of Macular Degeneration by an Ophthalmologist
Light sensitivity in the macular retina that is at least 10 dB units worse than in peripheral regions, as demonstrated by a scanning laser ophthalmoscope (MAIA)
Disqualifiers
Pacemaker or any ferromagnetic metal implanted in their body
Metal of any type implanted in their head (limited dental work is acceptable)
Claustrophobia
Being hearing-impaired
Trial design
Design model
Parallel
Treatments tested in this trial
Training visual sensitivity
BehavioralInvestigators adopt a standard PL approach to train early visual processes of discriminating the orientation of Gabor patches presented at threshold contrast. Across training blocks, Gabors will range in spatial frequency, where contrast is adapted with a 3/1 staircase. Whenever a specific contrast threshold is reached, spatial frequency will increase by 2 cycles per degree and contrast will be reset. Preliminary data from this method in normally seeing and MD participants show both feasibility and tentative evidence that this training gives rise to improvements in acuity.
Combination training
BehavioralDaily tasks involve a combination of being sensitive to basic visual features, being able to integrate these features, and directing attention and eye movements to better evaluate the information of potential interest. To address this integrative nature of real-world vision, this condition combines elements of training visual sensitivity, spatial integration, and spatial attention.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Training visual sensitivityExperimental treatment 1 intervention
Group B: Combination trainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline Radial Bias from the Crowding Task after completion of Training at approximately 7 weeks
The ratio of the crowding threshold along the axis connected to the fovea vs. along the orthogonal axis.
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average2
Change from Baseline Saccadic Precision after Completion of Training at approximately 7 weeks
Consistency across trials in placement of the first saccade calculated by the distribution across trials (bivariate contour ellipse area) of the landing point of the first fixation of each trial.
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average3
Change from Baseline Fixation Stability after Completion of Training at approximately 7 weeks
Normalizing fixations in the PRL to the first fixation to that region and calculating the distribution of all fixation locations in this normalized space (measured as a bivariate contour ellipse area).
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on averageOther outcomes
1
Change from Baseline Acuity after Completion of Training at approximately 7 weeks
Acuity threshold from the Landolt C task.
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average2
Change from Baseline Contrast Sensitivity after Completion of Training at approximately 7 weeks
Threshold value from contrast sensitivity task.
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average3
Change from Baseline Minimal print size from the MNREAD task after Completion of Training at approximately 7 weeks
Minimal print size from the MNREAD task
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on average4
Change from Baseline Precision of Reconstructed Representation of Stimulus Orientation after Completion of Training at approximately 7 weeks
Precision of reconstructed representation of stimulus orientation (quantified with FWHM)
Time frame
Baseline and Within 3 weeks of training completion, training is complete 7 weeks from baseline on averageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
University of California, Riverside
Collaborator
Source ClinicalTrials.gov