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A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
Rochester, MN
The purpose of this study is to evaluate and compare 2 doses of AGTC-501 to an untreated control group. A single subretinal injection of AGTC-501 (300 μL containing either 2.6 × 1011 vg/mL [low dose] or 2.4 × 1012 vg/mL [high dose]) will be administered in subjects in 2 treatment groups (N=~42), while subjects in the untreated control group (N=~21) will be followed and evaluated up to Month 12, after which they will be eligible to receive treatment with the high dose of AGTC-501.
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A Study to Evaluate the Argus II/ORCAM Device
Rochester, MN
The purpose of this study is to determine if wearable, text-to-speech (TTS) and visual pattern recognition (VPR) technology can be used to extend the capabilities of the Argus II to allow patients to read and recognize faces and objects. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. The FDA has approved the Argus II as a humanitarian device. Present-day wearable text-to-speech converters are also capable of object and face recognition. Such systems have been developed to assist with these tasks in patients with severe low-vision.
ORCAM is ...
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New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
Rochester, MN
This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.
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Outcome Measures for Clinical Trials in Pediatric Eye Care and Strabismus
Rochester, MN
This study is being done to:
- Assess what children with different eye conditions experience in everyday life
- Improve our understanding of the difficulties that children with eye problems experience
- Improve reporting of how parents see their child’s eye condition affecting them
- Assess what parents of children with different eye conditions experience in their own everyday life
- Improve the way we assess the benefits of treatment