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Manufacturer of the investigational device has ceased all business activities
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This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS. For Germany, it is under the exceptions mentioned in §23b MPG (Medizinproduktegesetz, German Medical Device Law). Its purpose is to collect data that is created during the regular therapy with the implant. No additional examinations are performed, except a patient questionnaire.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to device failure | Recording of device failures | 6 Years |
| Number, nature and severity of challenges or complications during surgical procedures | Recording of adverse events | 6 Years |
| Number, nature and severity of device-related adverse events and incidents until device failure or explantation | Recording of adverse events | 6 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Functional Vision Test | Eye-hand coordination: a cup should be placed in the middle of a plate | 6 Years |
| 2. Functional Vision Test | Activity of daily living - Table test: 4 white items of big plate, small plate, bowl, cup and cutlery are placed on a black table cloth and should be identified and touched |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who received a Retina Implant Alpha at the study site. Patients who are fulfilling specific criteria to receive a RETINA IMPLANT Alpha AMS.
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| Name | Affiliation | Role |
|---|---|---|
| Florian Gekeler, Prof Dr med | Katharinenhospital Stuttgart | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katharinenhospital Stuttgart | Stuttgart | 70174 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23427175 | Background | Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, Gekeler F, Greppmaier U, Hipp S, Hortdorfer G, Kernstock C, Koitschev A, Kusnyerik A, Sachs H, Schatz A, Stingl KT, Peters T, Wilhelm B, Zrenner E. Artificial vision with wirelessly powered subretinal electronic implant alpha-IMS. Proc Biol Sci. 2013 Feb 20;280(1757):20130077. doi: 10.1098/rspb.2013.0077. Print 2013 Apr 22. | |
| 26783453 |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| 6 Years |
| 3. Functional Vision Test | Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted | 6 Years |
| 4. Functional Vision Tests | Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described | 6 Years |
| Visual related quality of life (Patient reported outcome) | Impact of Vision Impairment - Very Low Vision Questionnaire (IVI-VLV) (Finger et al., 2014) is asking for vision-related quality of life by rating impact of eyesight on various tasks, referring to the last month | 6 Years |
| Background |
| Koitschev A, Stingl K, Bartz-Schmidt KU, Braun A, Gekeler F, Greppmaier U, Sachs H, Peters T, Wilhelm B, Zrenner E, Besch D. Extraocular Surgical Approach for Placement of Subretinal Implants in Blind Patients: Lessons from Cochlear-Implants. J Ophthalmol. 2015;2015:842518. doi: 10.1155/2015/842518. Epub 2015 Dec 10. |
| 25812924 | Background | Stingl K, Bartz-Schmidt KU, Besch D, Chee CK, Cottriall CL, Gekeler F, Groppe M, Jackson TL, MacLaren RE, Koitschev A, Kusnyerik A, Neffendorf J, Nemeth J, Naeem MA, Peters T, Ramsden JD, Sachs H, Simpson A, Singh MS, Wilhelm B, Wong D, Zrenner E. Subretinal Visual Implant Alpha IMS--Clinical trial interim report. Vision Res. 2015 Jun;111(Pt B):149-60. doi: 10.1016/j.visres.2015.03.001. Epub 2015 Mar 23. |
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |