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OpenTrials
Completed

NCT Number: NCT01024803

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.

Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.

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Key information

Conditions

Retinitis Pigmentosa Blindness Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helmut Sachs, MD, PD, Dresden, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones.
  • Pseudophakia
  • Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
  • Age between 18 and 78 years.
  • Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation.
  • Ability to read normal print in earlier life, optically corrected without magnifying glass.
  • Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2.

Exclusion criteria

  • Period of appropriate visual functions approx. 12 years / lifetime.
  • Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant.
  • Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
  • Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
  • Heavy clumped pigmentation at posterior pole
  • Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
  • Amblyopia reported earlier in life on eye to be implanted
  • Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
  • Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
  • Hyperthyroidism or hypersensitivity to iodine
  • Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
  • Participation in another interventional clinical trial within the past 30 days.

Treatment and study plan

Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye

Device

Surgical implantation of medical device named "Retina Implant" into eye to restore vision partially.

Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.

Other names: retinal implant, bionic eye, artificial vision, artificial eye, restoration of vision, eye chip, vision prosthesis, eye implant, retinal prosthesis

Primary outcomes

  1. Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.

    Time frame: every 3 months for a period of one year

Secondary outcomes

  1. Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.

    Time frame: every 3 months for a period of one year

  2. Patient long term safety and stability of implant function

    Time frame: every 3 months for a period of one year

Sponsors and collaborators

Lead sponsor

Retina Implant AG

Industry

Registry information

Official study title

Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Important dates

Study start
2009
Primary completion
2017
Study completion
2018
First posted
Dec 3, 2009
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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