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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01835002
Eligibility Criteria:
Inclusion Criteria:
* patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
* adult patients who are capable of giving consent,
* Visual acuity ≥ 0.02
* because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
* the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol
Exclusion Criteria:
* diabetic retinopathy
* neovascularisation of any origin
* after arterial or venous occlusion
* after retinal detachment
* silicone oil tamponade
* dry or exudative age-related macular degeneration
* macular edema
* all forms of glaucoma
* any form of corneal degeneration that reduces visual acuity
* systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
* patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
* forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
* simultaneous participation in another interventional study or history of interventions whose effect may still persist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01835002
Study Brief:
Protocol Section:
NCT01835002