Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients | Recruiting
Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients
Health Conditions
  • Retinitis Pigmentosa
  • Retinal Degeneration
Recruiting
Recruitment Status
NCT01024803
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • 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.; every 3 months for a period of one year
Secondary Outcome Measures
  • 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.; every 3 months for a period of one year; Patient long term safety and stability of implant function; every 3 months for a period of one year
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
Germany; Hungary; Italy; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 78 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
45
Participant Inclusion Criteria
  • 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.
Participant Exclusion Criteria
  • 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.
Interventions
Device; Device name: "Retina Implant model Alpha". Surgical implantation of medical device into eye; 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.; []
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific 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
Secondary Trial Identifying Number
Sorry, this information is not available
Website
Sorry, this information is not available
Study Funded By
Retina Implant AG
Funder Type
Sorry, this information is not available
Study Sponsored By
Retina Implant AG
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

26 Nov 2009

Last Updated

11 Jul 2014

Date Record Refreshed on UKCTG

31 Jul 2015