Treatment Trials

8 Clinical Trials for Various Conditions

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SUSPENDED
V-NAV Usability Study: End Users Trying the Vortant Indoor Navigation Tool
Description

The study will begin with an explanatory/training session where individuals with low vision will learn to use the V-NAV (Vortant NAVigation tool) indoor navigation app, and will have the opportunity to try it for a few representative tasks. The main activity includes a take-home trial, an extended unstructured period to emulate the post-purchase experience of users, during which participants will have the opportunity to use the V-NAV in their everyday lives. Data will be collected from the users to measure the relative advantage of V-NAV compared to the user's current indoor navigation method.

RECRUITING
Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
Description

This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.

RECRUITING
Advanced Spatiomotor Rehabilitation for Navigation in Blindness & Visual Impairment
Description

One of the most challenging tasks for blind and visually impaired individuals is navigation through a complex environment. The goal of the present multidisciplinary study is to increase spatial-cognition abilities in people who are blind or visually impaired through training with the previously-developed Cognitive-Kinesthetic Rehabilitation Training to improve navigation, and to investigate the resultant neuroplastic brain reorganization through multimodal brain imaging. In accordance with National Eye Institute (NEI) strategic goals, this multidisciplinary project will promote the development of well-informed new approaches to navigational rehabilitation, memory enhancement and cross-modal brain plasticity to benefit 'cutting edge' fields of mobile assistive technologies, vision restoration and memory facilitation for the aging brain.

TERMINATED
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Description

Background: CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years. Researchers want to test an assistive device that may help children with CLN3 or with non-CLN3 related blindness. Objective: To learn if it is safe, easy, and useful for children with CLN3 or with non-CLN3 related blindness to use the OrCam. Eligibility: People aged 6-18 years who have either CLN3-related disease or non-CLN3 related blindness. Design: Participants will be screened with the following: Medical history Physical exam Family history Eye exam and vision tests. They will get eyedrops to dilate their eyes. Psychological and neurocognitive tests. They will be asked questions and observed for how they do various tasks, such as talking, playing, writing, drawing, and solving problems. Hearing tests. They may wear headphones or earplugs. Electrodes may be taped to their head. Blood samples Skin biopsy, if needed Cheek cell, saliva, or urine samples The OrCam is the size of and weighs about half as much as a pack of gum. It is attached to eyeglass frames by magnets. Participants will do tasks before and after they have been trained on the OrCam. They will do these tasks without or with using the OrCam. Participants will be given an OrCam to use for 1 week or 1 month. They will have check-in sessions with the study team. Participants and/or their caregivers will be asked about abilities, behaviors, social skills, learning methods, intelligence, and health-related quality of life. Participants samples may be used for genetic testing and/or to make a type of stem cell. Participation will last for 1-5 weeks.

SUSPENDED
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
Description

This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.

NOT_YET_RECRUITING
Validation of Texture Changing Coatings for Use in At-Home Rapid Tests
Description

At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.

RECRUITING
Testing Tactile Aids With Blind Subjects
Description

The objective of this project is to create richer tactile aids by using materials chemistry to create tactile sensations in tactile aids, as an alternative to traditional physical bumps, lines, or textures. These materials are commonly used in household products, but have not yet been used to enrich tactile aids. Successful outcomes are primarily the accuracy with which low vision or blind subjects identify objects made from tactile coatings versus traditional tactile aids. Other outcomes include time to completion of the task, or the number of distinctive categories that participants can identify.

RECRUITING
Stem Cell Ophthalmology Treatment Study II
Description

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.