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

Retina Implant AG

Status

Completed

Conditions

Retinal Degeneration

Retinitis Pigmentosa

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

RI-MC-CT-2009

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 78 years old

Volunteers

No Healthy Volunteers

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.