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 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT05416268
Eligibility Criteria:
Inclusion Criteria:
* Male or female at least 22 years of age on day of enrollment
* BCVA letter score of 75 or better (Snellen equivalent of 20/32 or better) on day of enrollment
* Eyes are healthy/normal based on prior examinations, record review, and/or patient intake questions. Subject has not been diagnosed with any ocular pathology that could affect ERG results.
* Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
* Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines
Exclusion Criteria:
* A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D on day of enrollment
* Intraocular surgery (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment)
* Any prior macular or panretinal photocoagulation laser treatment
* History of ophthalmic or neurologic condition known to affect visual function
* Inability to obtain a reliable ERG test
* History of Diabetic retinopathy
* History of Glaucoma
* History of ARMD
* History of seizure disorder
* Has an open sore(s) or dermatological condition that may come in contact with the electrodes/electrode arrays
* In the opinion of the Investigator, is unlikely to comply with the study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05416268
Study Brief:
Protocol Section:
NCT05416268