Table 4.
Device | Electrode specifications | Size | Advantages | SAE/AEs | Clinical Status |
---|---|---|---|---|---|
Gen 2 suprachoroidal device | 44 active electrodes (44 × 1 μm diameter) | 19 × 8 mm |
- Decreased surgical complexity - Less risk of intraoperative and post operative complications - All subjects demonstrated improvement on localization tasks with device on - Expected to be suitable for at home use |
No device-related SAEs | Completed clinical trial with 4 patients with RP showing to be suitable for long-term use in humans with RP |
Phoenix-99 | 98 stimulation electrodes and one returning electrode | 18.7 × 10.8 mm nominal thickness of 500 μm | Information not available |
- Corneal abrasion/opacity - Corneal ulcer - Swelling - Limited blinking - Red eye - Weeping wound, discharge, light bleeding - Suture related - Dislodged orbital grommet (without erosion or VS movements) - Dislodged orbital grommet with erosion through conjunctiva and VS dislodgement - Retinal haemorrhage - Suspected retinal haemorrhage - Limited eye movements - Elevated IOP ≥ 35 mm Hg - Herniated choroid during array insertion |
Completed in vivo safety study |
STS |
49 electrodes (500 Jim diameter and 500 Jim height) |
5.8 × 5.2 × 0.5 mm |
- Covers a large visual field - conforms to the curvature of the eye - long term use |
- moderate edema and hematomas observed in periorbital and head regions - Conjunctival chemosis and injection observed in all cases |
Completed in vivo study of wide-field dual-array STS prosthesis |