An interventional study of 44Ch Bionic Eye Device in Retinitis Pigmentosa and Choroideremia, sponsored by Mobius Medical Pty Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Mobius Medical Pty Ltd. · Not applicable, Interventional, and Treatment
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
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).
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's enrollment of 4 is below the median of 27 across 179 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →This is the only study on the registry with Mobius Medical Pty Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.
Time frame: 2 years
Efficacy - visual response
The ability to generate a visual response accessed via repeatable threshold measurements of visual perception.
Time frame: 2 years
Visual Function and Functional Vision
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.
Time frame: 2 years
Quality of life - IVI - very low vision validated questionnaire
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.
Time frame: 2 years
Plan to share: No
Ran from Feb 2018 to primary completion in Dec 2020, 34 months.
Of 30 interventional studies with no phase under Retinitis Pigmentosa, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 154. This study's 34 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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