CompletedNot Applicable

Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm

Russia78 participantsStarted 2021-10-01

Plain-language summary

Some parameters, such as a change in the optic tilt and axial decentration, can affect the optical characteristics of intraocular lenses (IOLs) in postoperative period, which leads to residual refractive errors and other complications. The stability of the intraocular lens in the eye is largely dependent on the mechanical design of its haptic support elements. Thus, the new Clareon IOL has a flat haptic with a flexible design that minimizes axial changes and allows the IOL to maintain a stable position in a given plane during compression. Currently there is no published data of the stability for Clareon AutonoMe IOL for long eyes. The purpose of the current study is to evaluate and compare the axis displacement and stability of optical tilt, visual and refractive results in patients after implantation of two different models of intraocular lenses: Clareon AutonoMe (Alcon, USA) and Hoya iSert 251 (Japan) in the long-term postoperative period (after cataract surgery).

Who can participate

Age range

50 Years – 78 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 percepti…

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
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Questions for the trial coordinator

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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraocular lens axial displacement

Timeframe: 6 months

Trial details

NCT IDNCT05129566

SponsorThe S.N. Fyodorov Eye Microsurgery State Institution

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Cataract Senile trials