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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT07085533
Eligibility Criteria:
Inclusion Criteria:
1. Color Perception and Communication Ability Participants must have the ability to verbally identify or describe colors and test stimuli. This requires adequate cognitive and communicative capacity to understand instructions and respond appropriately during color vision testing.
2. Diagnosis of Inherited Retinal Dystrophy (IRD Group Only) Participants assigned to the IRD group must have a confirmed clinical diagnosis of an inherited retinal dystrophy
3. No Evidence of Inherited Retinal Disease (Control Group Only)
Participants in the control group must have:
* No known history or clinical evidence of inherited retinal degeneration
* Normal retinal health or only non-retinal ocular conditions not affecting retinal function (e.g., mild cataract, corrected refractive error)
* Normal or expected-normal color vision
Exclusion Criteria:
1. Non retinal causes of color vision loss
* Optic neuropathies (e.g., optic neuritis, glaucoma related optic nerve damage)
* Cortical vision impairments affecting color perception
* Any other neurological or optic nerve pathology causing color vision deficiency
2. Psychological or cognitive conditions affecting color perception or communication
* Severe developmental delays
* Cognitive impairments interfering with ability to comprehend or reliably perform color vision tests
* Psychiatric conditions that impair visual interpretation or reliable testing
3. Prior treatment with potential transient effects on the retina
* Recent retinal surgery
* Recent drug therapy affecting retinal structure or function
* Any acute intervention that might confound the correlation analyses due to lack of a stable baseline
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07085533
Study Brief:
Protocol Section:
NCT07085533