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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT03281005
Eligibility Criteria:
Inclusion Criteria for patients with retinitis pigmentosa:
* Age: ≥ 20 years
* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent
Inclusion Criteria for healthy Volunteers:
* Age: ≥ 35 and ≤ 75 years
* Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening
Exclusion Criteria:
* Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months
* Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study
* Pregnant women
* Subjects who are judged that continuation of the study is difficult during the study period
* Subjects who are employed by the company sponsoring this study, an organization or institution related to this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03281005
Study Brief:
Protocol Section:
NCT03281005