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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02588430

Enrollment

Registered

2015-10-27

Start date

2019-03-31

Completion date

2030-06-30

Last updated

2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results