Retina Implant Pilot Trial to Evaluate Safety & Efficacy in Blind Patients Having Degenerated Photo-receptors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-12-31

Brief Summary

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The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina. This pilot study will give important information on safety and efficacy of sub-retinal implants.

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Detailed Description

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Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition, the quality of the image transmitted in this first human application cannot be foreseen. On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps.

Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, 2

During measurement/test periods, investigator sets implant into ON or OFF condition without subjects knowledge of when device is active.

Group Type EXPERIMENTAL

Retina implant is surgically placed into subretinal position

Intervention Type DEVICE

Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.

Interventions

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Retina implant is surgically placed into subretinal position

Subretinal implant is either in ON or in OFF condition during test periods, such as FrACT, BaLM, grating, orientation \& mobility.

Intervention Type DEVICE

Other Intervention Names

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Retina Implant, subretinal implant, vision prosthesis, medical device for restoration of vision

Eligibility Criteria

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Inclusion Criteria

* Hereditary retinal degeneration of the outer retinal layers with the retinal vessels still being perfused and pigments of mild to moderate density
* Blindness (at least monocular) or visual functions not appropriate for navigation/orientation
* Period of appropriate visual functions \> 12 years / lifetime
* Visual acuity ≥ 0,05 in earlier life
* Electrically Evoked Phosphenes provide evidence of inner-retinal function.
* willing and able to give written informed consent

Exclusion Criteria

* Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathy, trauma, diabetic retinopathy, retinal detachment)
* Systemic disease that might imply considerable risk with regard to the surgical intervention and anesthesia (e.g. cardiovascular diseases, severe metabolic diseases)
* Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression )
* Retina detected as too thin (\< 100 µm) to expect required rest-functionality as shown via Optical Coherence Tomography (OCT).
* 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 clinical trial within the past 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No