Study of a Suprachoroidal Retinal Prosthesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03406416|
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : August 16, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa Choroideremia||Device: 44Ch Bionic Eye Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study|
|Actual Study Start Date :||February 13, 2018|
|Actual Primary Completion Date :||December 18, 2020|
|Actual Study Completion Date :||December 18, 2020|
Experimental: Suprachoroidal retinal prosthesis
Prototype wide view suprachoroidal retinal prosthesis
Device: 44Ch Bionic Eye Device
Prototype wide view suprachoroidal retinal prosthesis
- 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.
- Efficacy - visual response [ Time Frame: 2 years ]The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
- 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:
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
- 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
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
|Centre for Eye Research Australia|
|Melbourne, Victoria, Australia, 3002|
|Principal Investigator:||Penelope Allen, FRACO, FRACS||Centre for Eye Research Australia|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Mobius Medical Pty Ltd.|
|Other Study ID Numbers:||
|First Posted:||January 23, 2018 Key Record Dates|
|Last Update Posted:||August 16, 2021|
|Last Verified:||August 2021|
|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|
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Genetic Diseases, X-Linked