Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Terminated

• Conditions: Outer Retinal Degeneration; Retinitis Pigmentosa

• Registration Number: NCT01490827
• Lead Sponsor: Second Sight Medical Products

Brief Summary

This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

Detailed Description

This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Adults, age 25 year or older

• with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
• Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
• Have previous history of useful form vision
• Have consented to participate in the study
• Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
• At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Exclusion Criteria

• Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.)

• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.)

• Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity)

• Pre-disposition to eye rubbing

• Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

  • cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
  • psychiatric disease including diagnosed forms of depression;
  • does not speak a principal language associated with the region, and
  • deafness or selective frequency hearing loss that prevents hearing device alarms and alerts

• Participants who are pregnant or wish to become pregnant during the course of the study

• Participation in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;

• Conditions likely to limit life to less than 1 year from the time of inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse events	up to 3 years from time of implantation	nature and rate of adverse events

Secondary Outcome Measures

Name	Time	Method
visual function	up to 3 years from time of implantation	Square localization, direction of motion, grating visual acuity

Trial Locations

Locations (10)

University Medical Center Schleswig-Holstein, Department of Ophthalmology; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Klinikum rechts der Isar - Technical University; 🇩🇪 Munich, Bavaria, Germany

Augenklinik des Staedtischen Klinikums; 🇩🇪 Karlsruhe, Baden-Wurttemberg, Germany

Knappschaftsklinikum Saar, Department of Ophthalmology; 🇩🇪 Sulzbach, Saarland, Germany

Center for Ophthalmology - University of Koln; 🇩🇪 Koln, NRW, Germany

RWTH University Eye Clinic; 🇩🇪 Aachen, Germany

ULSS 15 Alta Padovana Hospital; 🇮🇹 Camposampiero, Veneto, Italy

University of Pisa Eye Surgery Department; 🇮🇹 Pisa, Toscana, Italy

University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde; 🇩🇪 Hamburg, Germany

Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde; 🇩🇪 Leipzig, Germany