Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT04295304
Eligibility Criteria:
Inclusion Criteria:
* Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy
* Visual acuity in both eyes from light perception to no light perception
* Confirmed functional ganglion cells and optic nerve in the implanted eye
* History of useful vision
* Mentally competent
Exclusion Criteria:
* Diseases or condition that affect retinal and or optic nerve function
* Optic Nerve diseases
* Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning
* Dry eye
* Pre-disposition to eye rubbing
* Posterior pole severe staphyloma
* Strabismus superior to 10 prismatic diopter
* Severe nystagmus
* Corneal endothelium density \< 1500 cells/mm2
* Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric
* Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age.
* Hyperthyroidism or hypersensitivity to iodine
* Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression)
* Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study
* Conditions likely to limit life to less than 1 year from time of recruitment to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04295304
Study Brief:
Protocol Section:
NCT04295304