NCT03561922

Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Retina Implant AG · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.

Detailed description

This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires. This study adheres to the tenets of the Declaration of Helsinki.

Conditions

• Retinal Degeneration
• Inherited Retinal Dystrophy Primarily Involving Sensory Retina

Interventions

Type	Name	Description
DEVICE	RETINA IMPLANT Alpha AMS	Implantation of the subretinal RETINA IMPLANT Alpha AMS

Timeline

• Start date: 2018-09-04
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2018-06-19
• Last updated: 2019-04-19

Locations

2 sites across 1 country: France