PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Overview

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.

Full Title of Study: “Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2029

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.

Clinical Trial Outcome Measures

Primary Measures

  • Time to device failure
    • Time Frame: 6 Years
    • Recording of device failures
  • Number, nature and severity of challenges or complications during surgical procedures
    • Time Frame: 6 Years
    • Recording of adverse events
  • Number, nature and severity of device-related adverse events and incidents until device failure or explantation
    • Time Frame: 6 Years
    • Recording of adverse events

Secondary Measures

  • 1. Functional Vision Test
    • Time Frame: 6 Years
    • Eye-hand coordination: a cup should be placed in the middle of a plate
  • 2. Functional Vision Test
    • Time Frame: 6 Years
    • 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
  • 3. Functional Vision Test
    • Time Frame: 6 Years
    • Activity of daily living – Clothes sorting: socks in white, grey and black should be sorted
  • 4. Functional Vision Tests
    • Time Frame: 6 Years
    • Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described
  • Visual related quality of life (Patient reported outcome)
    • Time Frame: 6 Years
    • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who received a RETINA IMPLANT Alpha AMS. – Patients willing and able to give written informed consent. Exclusion Criteria:

  • none

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Implant AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Florian Gekeler, Prof Dr med, Principal Investigator, Katharinenhospital Stuttgart

References

Stingl K, Bartz-Schmidt KU, Besch D, Braun A, Bruckmann A, Gekeler F, Greppmaier U, Hipp S, Hörtdörfer 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.

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.

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.

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