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

Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant 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.

Study Overview

• Status: Withdrawn
• Conditions: Retinitis Pigmentosa

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70174
    • Katharinenhospital Stuttgart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Retina Implant AG
• Investigators: Principal Investigator: Florian Gekeler, Prof Dr med, Katharinenhospital Stuttgart

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): December 1, 2029
• Study Completion (Anticipated): June 1, 2030

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: RI-PMCF1-EU