Age-related Macular Degeneration Clinical Trial
Official title:
Remapping the Visual Field to Aid Reading With Central Scotomas
Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.
Following initial characterization of their visual field loss, the participant's performance in reading tasks will be measured with and without remapping. Tasks will include reading groups of random letters, words, simple sentences, and "natural" text from the environment (taken from phone apps, signage, etc). Different kinds of remappings will be used by participants, including traditional and personalized remapping. For control observers, differently shaped artificial scotomas will be used. Participants interested in the study will be brought in for an initial visit. All participants will be administered the MMSE. Observers who pass the criteria for the study will then have the remainder of the procedures described to them verbally prior to undergoing the remainder of the consent process (see below). Participants will then undergo a standard exam at the UMN eye clinic, if they have not had one within the last month. Participants will then have their scotomas mapped using a microperimeter housed in the psychology department to give size and shape information. Additional perimetry may also be conducted using either of the two displays (either HMD or desk mounted computer monitor) we have developed. Here, patients will be asked to fixate at a spot on screen and identify visual stimuli presented at different regions of the screen. The size and locations of visual stimuli patients were unable to identify will provide the size and location of the scotoma. Another additional manual perimetry protocol may be conducted as well. This would involve asking subjects to fixate at the center of a tangent screen, and asking them to identify dots temporarily presented on the screen by the researcher using a laser pointer. The locations of dots that patients are unable to identify will provide the size and location of the scotoma. The location and extent of each eye's scotoma and PRL will be used as software inputs on either device. Perimetry using one or all of the methods above will be performed until acceptable information about the scotoma extent and location is obtained. In a second visit, participants will perform the visual tasks that are used as the basis of their personalized remapping, letter perimetry. Participants will first view and report three randomly selected horizontally arranged letters placed at different locations in the visual field. This letter perimetry task will take about 40 min and will cover a large part of the visual field. Participants will then read single words whose letters have been displaced from horizontal in various ways that comprise candidate remappings generated on the basis of the letter perimetry results. This personalization test will take about 40 minutes, and will find a good remapping strategy for the individual. Subjects will then be introduced to the reading tasks that comprise the remainder of the study In 6 additional sessions, participants will perform various reading tasks using different remappings. In all of these, text will be displayed on the screen, and the task is simply to read aloud what was presented. Two sessions will involve reading single words, one session will involve reading strings of 3 letters that are not arranged horizontally, two sessions will involve reading short sentences, and one session will involve reading naturalistic text (from phone apps, signage, menus, etc). In all sessions, some reading will be with remapping, some will be without. Both traditional and personalized remapping will be used. In all these sessions, the eye tracker will be calibrated to participants' individual head and eye position. This will involve fixating at different points on the device screen (HMD or desk-mounted) as the eye is imaged by the eye trackers. This may take up to 45 minutes in the initial session, if various combinations of head and eye positions are required for the eye trackers to work well. But once completed, calibration is much faster in subsequent sessions. Quick perimetry validation may also be conducted in each session. Throughout all testing, patients will be asked if they feel any discomfort, and will be able to take a break or quit testing at any point. Including the initial visit, testing for any given patient is anticipated to last no more than eight sessions over eight weeks. Enrolling participants, testing, and data analysis for all participants is anticipated to take five years from the date of enrollment of the first participant. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05984927 -
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05536297 -
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT04005352 -
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
|
Phase 3 | |
Withdrawn |
NCT02873351 -
A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02802657 -
Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
|
Phase 4 | |
Not yet recruiting |
NCT02864472 -
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
|
Phase 4 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT01445548 -
Sirolimus for Advanced Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02035722 -
Intravitreal Injections-related Anxiety
|
Phase 2/Phase 3 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01048476 -
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01174407 -
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
|
N/A | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00345176 -
Age-Related Eye Disease Study 2 (AREDS2)
|
Phase 3 | |
Completed |
NCT02140151 -
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02555306 -
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT04796545 -
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
|
N/A | |
Completed |
NCT03166202 -
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
|
||
Completed |
NCT01397409 -
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
|
Phase 2 |