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Study of a Suprachoroidal Retinal Prosthesis

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ClinicalTrials.gov Identifier: NCT03406416
Recruitment Status : Enrolling by invitation
First Posted : January 23, 2018
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Bionic Vision Technologies
Centre for Eye Research Australia
Bionics Institute
University of Melbourne
Data 61 CSIRO
Australian National University
Information provided by (Responsible Party):
Mobius Medical Pty Ltd.

Brief Summary:
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Choroideremia Device: 44Ch Bionic Eye Device Not Applicable

Detailed Description:
Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Suprachoroidal retinal prosthesis
Prototype wide view suprachoroidal retinal prosthesis
Device: 44Ch Bionic Eye Device
Prototype wide view suprachoroidal retinal prosthesis




Primary Outcome Measures :
  1. Number and severity of device related serious adverse events (SAEs) [ Time Frame: 2 years ]
    The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 2 years ]
    The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.

  2. Visual Function and Functional Vision [ Time Frame: 2 years ]

    Visual function and Functional Vision will be scored from performance on a range of acuity, orientation and mobility, and activities of daily living tasks. Outcome measures include:

    1. Grating visual acuity: record the grating acuity level and average response time.
    2. Square localization: response error and response time is measured.
    3. Motion detection: response error and response time is measured.
    4. Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded.
    5. Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded.
    6. Obstacle avoidance task: task time and number of collisions is recorded.
    7. Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.

  3. Quality of life [ Time Frame: 2 years ]
    Quality of life will be assessed via survey and self-report. The Functional Low Vision Observer Assessment (FLORA) is a questionnaire that will be used to measure participants changes in participant daily living experiences.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years or older
  • Either gender
  • A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia
  • Remaining visual acuity of bare light perception or less in both eyes
  • Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response
  • A history of at least 10 years of useful form vision in the worse seeing eye

Exclusion Criteria:

  • Optic nerve disease (history of glaucoma of More than 1 month, or history of any other optic neuropathy)
  • Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.
  • Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)
  • Any ocular condition that predisposes the participant to rubbing their eyes
  • Cognitive deficiencies, including dementia or progressive neurological disease
  • Psychiatric disorders, including depression, as diagnosed by a qualified psychologist
  • Deafness or significant hearing loss
  • Inability to speak or understand English
  • Pregnancy
  • Presence of a cochlear implant
  • Participant enrolled in another investigational drug or device trial for the treatment of their ocular condition
  • Poor general health, which would exclude them from obtaining a general anaesthetic
  • Unrealistic expectations of the investigational device to provide functional vision
  • Poorly controlled diabetes
  • Epilepsy
  • Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained)
  • Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406416


Locations
Australia, Victoria
Centre for Eye Research Australia
Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Mobius Medical Pty Ltd.
Bionic Vision Technologies
Centre for Eye Research Australia
Bionics Institute
University of Melbourne
Data 61 CSIRO
Australian National University
Investigators
Principal Investigator: Penelope Allen, FRACO, FRACS Centre for Eye Research Australia

Publications:
Responsible Party: Mobius Medical Pty Ltd.
ClinicalTrials.gov Identifier: NCT03406416     History of Changes
Other Study ID Numbers: BVT_001
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Choroideremia
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Choroid Diseases
Uveal Diseases
Genetic Diseases, X-Linked