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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT02144103
Eligibility Criteria:
Inclusion Criteria:
* Patient suffers from primary open-angle glaucoma (II and III stages; singe eye or both eyes) at least for 6 months
* Intraocular pressure is stable for at least for 3 months
* Visual acuity of each eye (measured by using visual acuity charts projector) not less than 0,1
* Patient is familiar with Participant information sheet
* Patient signed informed consent form
Non-inclusion Criteria:
* Contraindications to the local anesthesia or medical history of allergic reactions to local anesthetics
* Any anomalies or conditions of at least one eye which can limit tonometry implementation
* Inflammatory disease of at least one eye or auxiliary apparatus (both infectious and non-infectious etiology: conjunctivitis, keratitis, uveitis, dacryocystitis etc.)
* Medical history of surgery on at least one eye during preceding 6 months.
* Medical history of heavy traumatic injury of eyes
* Patient has a cataract with high degree of lens opacification which can limit planned eye examination
* Patient prescribed for systemic corticosteroids or other medications treatment with proven effect leading on intraocular pressure increase
* Medical history or present dry eye syndrome accompanied by corneal and conjunctival xerosis
* Subcompensated or decompensated forms of chronic diseases of internal organs
* Clinically significant abnormalities in results of laboratory tests
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
* Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
* Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment
* Acute vascular pathology
* Age-related macular degeneration
Exclusion Criteria:
* Patient's refusal from the further participation in trial
* Patient's refusal from compliance with the requirements of contraception during the participation in research
* Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections
Dropout Criteria:
* Direct indications on immediate initiation of treatment with medications with proven effect leading to intraocular pressure increase
* Pregnancy
* Development of cataract with high degree of lens opacification which can limit planned eye examination
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02144103
Study Brief:
Protocol Section:
NCT02144103