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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT01878032
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Participants must be 5 years of age or older.
2. Participant (or legal guardian) must understand and sign the protocol s informed consent document.
3. Participant must be able to cooperate with the testing required for this study.
4. Participant s eyes must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography.
5. For IRD Participants only:
1. Participant must have IRD, defined as evidence of retinal rod- and cone-mediated
dysfunction and degeneration established by standard clinical methods including field tests, ERG, and imaging.
2. Participant must have a measurable visual acuity.
6. For Healthy Volunteers only:
1. Participant must have visual acuity of 20/20 or better.
EXCLUSION CRITERIA:
1. Participant is taking medications known to alter color vision, such as hydroxychloroquine (Plaquenil ), sildenafil (Viagra ), ethambutol, chloroquine amiodarone, and pamidronate disodium.
2. Participant has another ocular disease that may confound the study results, such as diabetic retinopathy, vascular occlusions, retinopathy related to drug toxicity, optic neuropathy, or central serous chorioretinopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT01878032
Study Brief:
Protocol Section:
NCT01878032