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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT05129566
Eligibility Criteria:
Inclusion Criteria:
* Man or woman 50 years and older with indicated cataract surgery.
* Signed informed consent, given by the participant or his/her legal representative.
* Ability to understand Russian spoken and written language.
* Sanitated oral cavity.
* Intraocular pressure in normal range.
* Axial eye length\> 26 mm.
* Corneal astigmatism \<1.0 diopters.
* The presence of age-related cataract with high myopia and low visual acuity (less than 0.5 with correction), the cornea thickness in the central optical zone is not less than 500 microns and not more than 600 microns, and the density of endothelial cells is higher than 2300 cells / mm2.
* Patients who have passed the entire tests for hospitalization in hospital and also have received the admission (the conclusion) of the therapist for the surgery.
Exclusion Criteria:
* Inability to give signed informed consent.
* Age under 50 years.
* History of allergic reactions to antibiotics, glucocorticosteroids, medications for local and general anesthesia.
* Diagnosed neoplastic process or treatment for tumor disease.
* Positive tests for infectious: HIV, syphilis, Hepatitis B, Hepatitis C.
* Any medical, psychiatric and/or condition, including cachexia, or social conditions that the investigator believes would interfere with or contraindicate adherence to the research protocol or the ability to provide signed informed consent.
* Active ophthalmic infection.
* Uncontrolled glaucoma
* Retinal defunctioning (no light perception and/or retinal detachment).
* Absence of the electric activity of the optic nerve and/or retina.
* Concomitant ocular pathology, such as the subluxation of the lens, glaucoma, pathology of the central retina, diabetic retinopathy, scars and opacities of the cornea, keratoconus, pathology of the corneal endothelium (Fuchs corneal dystrophy), pseudoexfoliative syndrome with pronounced impairment of the diaphragmatic function of the pupil, a non-functioning retina (lack of light perception and/or its detachment according to ultrasound examination), lack of electrical activity of the optic nerve and retina according to electrophysiological examination, etc.
* Patients with a serious general medical condition.
* Systemic use / administration of drugs that may affect the anatomical or functional characteristics of the cornea (amiodarone, β-blockers, tetracycline, etc.)
* Any pathology of the eye associated with myopia and myopic changes inside the eye (for example, myopic staphyloma) that may affect the results of the study.
* Regular intake of medications that may affect the proper function of the eye (antiglaucoma drugs, antibiotics, systemic immunosuppressive therapy, etc.)
* Systemic pathologies with possible damage to the cornea.
* Amblyopia.
* Any other concomitant ocular pathology, trauma or surgery in history.
* A patient who cannot adhere to the schedule of visits for research or treatment (for example, patients from other cities).
* Suspected drug or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
78 Years
Study:
NCT05129566
Study Brief:
Protocol Section:
NCT05129566