Clinical trial NCT02588430: PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Official title: Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Retinitis Pigmentosa
Lead sponsor: Retina Implant AG
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a Retina Implant Alpha at the study site. Patients who are fulfilling specific criteria to receive a RETINA IMPLANT Alpha AMS.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who received a RETINA IMPLANT Alpha AMS.
* Patients willing and able to give written informed consent.

Exclusion Criteria:

* none

Primary outcomes:
measure: Time to device failure
timeFrame: 6 Years
measure: Number, nature and severity of challenges or complications during surgical procedures
timeFrame: 6 Years
measure: Number, nature and severity of device-related adverse events and incidents until device failure or explantation
timeFrame: 6 Years
Secondary outcomes:
measure: 1. Functional Vision Test
timeFrame: 6 Years
measure: 2. Functional Vision Test
timeFrame: 6 Years
measure: 3. Functional Vision Test
timeFrame: 6 Years
measure: 4. Functional Vision Tests
timeFrame: 6 Years
measure: Visual related quality of life (Patient reported outcome)
timeFrame: 6 Years
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Katharinenhospital Stuttgart
Study officials:
affiliation: Katharinenhospital Stuttgart
name: Florian Gekeler, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.