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

NCT05129566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-04-23

No results posted yet for this study

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).

Conditions

  • Cataract Senile
  • Myopia, High-Grade
  • Corneal Astigmatism

Interventions

PROCEDURE

IOL Clareon AutonoMe

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).

PROCEDURE

IOL Hoya iSert 251

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).

Sponsors & Collaborators

  • Alcon Research

    collaborator INDUSTRY

  • The S.N. Fyodorov Eye Microsurgery State Institution

    lead OTHER_GOV

Principal Investigators

  • Boris E Malyugin, MD, PhD · The S. Fyodorov Eye Microsurgery Federal State Institution

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
78 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-31
Completion
2024-04-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129566 on ClinicalTrials.gov