Last updated: April 20, 2024
Sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Overall Status: Completed
Phase
N/A
Condition
Myopia
Eye Disease
Vision Loss
Treatment
IOL Hoya iSert 251
IOL Clareon AutonoMe
Clinical Study ID
NCT05129566
#108.1_06092021
Ages 50-78 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 lessthan 500 microns and not more than 600 microns, and the density of endothelial cellsis higher than 2300 cells / mm2.
- Patients who have passed the entire tests for hospitalization in hospital and alsohave received the admission (the conclusion) of the therapist for the surgery.
Exclusion
Exclusion Criteria:
- Inability to give signed informed consent.
- Age under 50 years.
- History of allergic reactions to antibiotics, glucocorticosteroids, medications forlocal 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 conditionsthat the investigator believes would interfere with or contraindicate adherence to theresearch 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, pathologyof 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 ofthe pupil, a non-functioning retina (lack of light perception and/or its detachmentaccording to ultrasound examination), lack of electrical activity of the optic nerveand retina according to electrophysiological examination, etc.
- Patients with a serious general medical condition.
- Systemic use / administration of drugs that may affect the anatomical or functionalcharacteristics of the cornea (amiodarone, β-blockers, tetracycline, etc.)
- Any pathology of the eye associated with myopia and myopic changes inside the eye (forexample, 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 (forexample, patients from other cities).
- Suspected drug or alcohol abuse.
Study Design
Total Participants: 78
Treatment Group(s): 2
Primary Treatment: IOL Hoya iSert 251
Phase:
Study Start date:
October 01, 2021
Estimated Completion Date:
April 20, 2024
Study Description
Connect with a study center
The S. N. Fyodorov Eye Microsurgery Federal State Institution
Moscow, 127486
Russian FederationSite Not Available
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