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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT03081468
Eligibility Criteria:
Inclusion criteria for participants with eye disease will include:
* Presence of RAPD as measured with RAPDx
* Presence of retinal disease, glaucoma or neuro-ophthalmic conditions that affect the optic nerve
* Male or female, aged 18 years or older
* Ability to understand nature/purpose of the study and to provide informed consent
* Ability to undergo binocular OCT imaging
* Ability to follow instructions and complete the study
* Ability to speak English
Exclusion criteria for participants with eye disease will include:
* Optical media opacity sufficient to preclude adequate ocular imaging with OCT
* Ptosis (drooping of the upper eyelid) sufficient to preclude visualization of the pupils using OCT
* Significant pupil irregularity that precludes reliable measurement of RAPD
* Any condition that is likely to interfere with pupillary constriction (e.g., iris pathology)
* Hearing impairment sufficient to interfere with hearing instructions
* Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
Inclusion criteria for healthy subjects will include:
* No self-reported ocular history (although wearing corrective prescription glasses is permitted)
* Male or female, aged 18 years or older
* Ability to understand nature/purpose of the study and to provide informed consent
* Ability to undergo binocular OCT imaging
* Ability to follow instructions and complete the study
* Ability to speak English
Exclusion criteria for healthy subjects will include:
* Presence of ocular pathology, including ptosis or pupil irregularities
* Hearing impairment sufficient to interfere with hearing instructions
* Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03081468
Study Brief:
Protocol Section:
NCT03081468