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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02588430
Other study ID # RI-PMCF1-EU
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2019
Est. completion date June 2030

Study information

Verified date April 2019
Source Retina Implant AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 ยง23b 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2030
Est. primary completion date December 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who received a RETINA IMPLANT Alpha AMS.

- Patients willing and able to give written informed consent.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Katharinenhospital Stuttgart Stuttgart

Sponsors (1)

Lead Sponsor Collaborator
Retina Implant AG

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to device failure Recording of device failures 6 Years
Primary Number, nature and severity of challenges or complications during surgical procedures Recording of adverse events 6 Years
Primary Number, nature and severity of device-related adverse events and incidents until device failure or explantation Recording of adverse events 6 Years
Secondary 1. Functional Vision Test Eye-hand coordination: a cup should be placed in the middle of a plate 6 Years
Secondary 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
Secondary 3. Functional Vision Test Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted 6 Years
Secondary 4. Functional Vision Tests Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described 6 Years
Secondary 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
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