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

Retinitis Pigmentosa Clinical Trial

Official title:

Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02588430
• Other study ID #: RI-PMCF1-EU
• Status: Withdrawn
• 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
• 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 §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.

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• Status: Withdrawn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:

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

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