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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03406416
Registration number
NCT03406416
Ethics application status
Date submitted
26/12/2017
Date registered
23/01/2018
Date last updated
16/08/2021
Titles & IDs
Public title
Study of a Suprachoroidal Retinal Prosthesis
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Scientific title
Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study
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Secondary ID [1]
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BVT_001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Retinitis Pigmentosa
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Choroideremia
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - 44Ch Bionic Eye Device
Experimental: Suprachoroidal retinal prosthesis - Prototype wide view suprachoroidal retinal prosthesis
Treatment: Devices: 44Ch Bionic Eye Device
Prototype wide view suprachoroidal retinal prosthesis
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number and severity of device related serious adverse events (SAEs)
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Assessment method [1]
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The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Efficacy - visual response
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Assessment method [1]
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The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Visual Function and Functional Vision
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Assessment method [2]
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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:
Grating visual acuity: record the grating acuity level and average response time.
Square localization: response error and response time is measured.
Motion detection: response error and response time is measured.
Table top task: locate and identify objects on a table. Accuracy rates and response times will be recorded.
Doorway detection task: to find doorway target. Task time and accuracy of door touch will be recorded.
Obstacle avoidance task: task time and number of collisions is recorded.
Functional Low Vision Observer Rated Assessment (FLORA): this assessment tool Is used to evaluate participant functional vision and mobility.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Quality of life - IVI - very low vision validated questionnaire
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Assessment method [3]
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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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Timepoint [3]
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2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/02/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/12/2020
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Sample size
Target
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Centre for Eye Research Australia - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Mobius Medical Pty Ltd.
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Bionic Vision Technologies
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Centre for Eye Research Australia
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Bionics Institute
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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University of Melbourne
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Data 61 CSIRO
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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Australian National University
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a proof of principal, to evaluate a safety and efficacy of a prototype
suprachoroidal retinal implant.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03406416
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Trial related presentations / publications
Ayton LN, Blamey PJ, Guymer RH, Luu CD, Nayagam DA, Sinclair NC, Shivdasani MN, Yeoh J, McCombe MF, Briggs RJ, Opie NL, Villalobos J, Dimitrov PN, Varsamidis M, Petoe MA, McCarthy CD, Walker JG, Barnes N, Burkitt AN, Williams CE, Shepherd RK, Allen PJ; Bionic Vision Australia Research Consortium. First-in-human trial of a novel suprachoroidal retinal prosthesis. PLoS One. 2014 Dec 18;9(12):e115239. doi: 10.1371/journal.pone.0115239. eCollection 2014.
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Public notes
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Contacts
Principal investigator
Name
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Penelope Allen, FRACO, FRACS
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Address
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Centre for Eye Research Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03406416
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