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Trial record 3 of 3 for:    Retina Implant Alpha AMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02588430
Recruitment Status : Withdrawn (Manufacturer of the investigational device has ceased all business activities)
First Posted : October 27, 2015
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Retina Implant AG

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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : June 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time to device failure [ Time Frame: 6 Years ]
    Recording of device failures

  2. Number, nature and severity of challenges or complications during surgical procedures [ Time Frame: 6 Years ]
    Recording of adverse events

  3. 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 Outcome Measures :
  1. 1. Functional Vision Test [ Time Frame: 6 Years ]
    Eye-hand coordination: a cup should be placed in the middle of a plate

  2. 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. 3. Functional Vision Test [ Time Frame: 6 Years ]
    Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588430


Locations
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Germany
Katharinenhospital Stuttgart
Stuttgart, Germany, 70174
Sponsors and Collaborators
Retina Implant AG
Investigators
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Principal Investigator: Florian Gekeler, Prof Dr med Katharinenhospital Stuttgart
Additional Information:

Publications:
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Responsible Party: Retina Implant AG
ClinicalTrials.gov Identifier: NCT02588430    
Other Study ID Numbers: RI-PMCF1-EU
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn