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).
The optical performance of intraocular lenses (IOLs) can be affected by changes in optic tilt and decentration that occur after implantation, resulting in residual refractive errors and other complications. Intraocular lens stability is largely dependent on the mechanical design of the haptics. 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. Based on our knowledge, nobody has compared Clareon AutonoMe and Hoya iSert 251 IOLs in clinical setting. Scientific Rationale: This study investigates the stability of IOLs in patients with long axial length. IOL stability on long eyes has a limited clinical data, no in Vivo research has been done. It is known that eyes with long axial length have a large capsule bag. With such eyes, it is difficult to predict the effective lens position. Each 0,5 mm axial displacement lead to approximately 0,5 D of the refractive error. For long eyes, it is important to use the latest generation of multi-component IOL calculation formulas for accurately prediction of effective lens position. The mail purpose of the 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). The research purpose is to evaluate the prediction error for each IOL calculation formula (Barrett Universal II, Kane, EVO, Holladay I with Van Koch correction)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Phacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration).
Phacoemulsification of cataract with implantation of two types of IOLs - Clareon AutonoMe and Hoya iSert 251. Operations will be performed by one surgeon using the Centurion vision system under control of the Verion navigation system. The Verion system will be used for capsulorhexis and IOL centration (limbus centration).
The S. N. Fyodorov Eye Microsurgery Federal State Institution
Moscow, Russia
Intraocular lens axial displacement
Axial displacement of the intraocular lens, stable position of the intraocular lens in the capsule bag after surgery, optics tilt, deviation from baseline, the distance from the corneal epithelium to the anterior surface of the intraocular lens, the stretching degree of the surgical wound will be assessed by the anterior segment OCT (AS-OCT).
Time frame: 6 months
Near and distance vision visual acuity
Improving the clarity of images of observed objects. For one focus distance (reading and working at near / far (depending on the calculation of the IOL for emmetropia or weak myopic refraction) / intermediate distance, it is possible to use spectacle correction in the postoperative period.
Time frame: 6 months
Patient's subjective satisfaction of with the quality of vision
Increased subjective satisfaction of patients with the quality of vision after surgery will be assessed using the VF-14 questionnaire (Steinberg E.P., 1994).
Time frame: 6 months
Deviation from emmetropic refraction
Accurate IOL calculation before surgery.
Time frame: 6 months
Number of intra- and postoperative complications
Intra- and postoperative complications in the operated eye will be assessed according to the observation data of the research subjects.
Time frame: 6 months
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