Study of a Suprachoroidal Retinal Prosthesis

August 13, 2021 updated by: Mobius Medical Pty Ltd.

Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Centre for Eye Research Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - visual response
Time Frame: 2 years
The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
2 years
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.
2 years
Quality of life - IVI - very low vision validated questionnaire
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mobius Medical Pty Ltd.

Collaborators

University of Melbourne
Australian National University
Centre for Eye Research Australia
Bionics Institute
Bionic Vision Technologies
Data 61 CSIRO

Investigators

  • Principal Investigator: Penelope Allen, FRACO, FRACS, Centre for Eye Research Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 14, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVT_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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