Table 1.
Study | Issues investigated |
---|---|
Study 1A | Obstructions to device insertion, adhesions |
Enucleated human eye (n = 14) | Location of scleral wound |
Relieving incision wound to accommodate axial length and scleral lead exit | |
Verify length of array to suit human eye size | |
Suture points of scleral patch | |
Dimensions of scleral patch | |
Study 1B | |
PNCB measurements (n = 10) | Location of PCNB relative to optic disc was investigated |
Study 2 | Surgical method in humans |
Whole human cadavers (n = 6) | Develop trocar design and surgical technique |
Lead orbit fixation method | |
Location of scleral wound and orbital notch | |
Location of scalp percutaneous pedestal wound | |
Scleral patch position to allow array position beneath macula | |
Angle of lead in orbit | |
Suture points of scleral patch | |
Study 3 | Expected variation in lateral canthus to pinna measurements assessed |
Lateral canthus to pinna (n = 61) | Information gathered informed lead length in the final device |
PNCB, posterior ciliary neurovascular bundle.