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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT04763369
Eligibility Criteria:
Inclusion Criteria:
* Patients who will be voluntarily participated for UMSCs injection for the treatment of RP.
* Patients who will be able to adhere to the study follow-up and protocol requirements.
* Individuals with age ranges from 18 years to 70 years will be included.
* Patients with best corrected visual acuity (BCVA) from 50 letters to 110 letters or \<20/50 in the ETDRS chart testing (Topcon CC-100 XP, Japan).
* Mean deviation values ranging between -33.0 and - 5.0 dB with compass visual field analysis (threshold 24-2, Sita Standard, Stimulus 3-white).
* Diagnosis of any phenotypic or genotypic variation of RP, confirmed by clinical history, fundus appearance, visual field, electroretinogram and genetic mutation analysis.
Exclusion Criteria:
* Presence of cataracts or other media opacity that might affect the visual field, mean deviation, or electroretinogram recordings.
* Presence of another ocular disease except RP (i.e., uveitis, strabismus, glaucoma) that causes visual field and optic disc changes.
* Presence of any systemic disorder that may affect visual functions. This includes diabetes, neurological disorders, and uncontrolled systemic hypertension.
* Smokers will be excluded from the study.
* Individuals who underwent ocular surgery except cataract extraction will be considered as excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04763369
Study Brief:
Protocol Section:
NCT04763369