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

NCT05129566 | Completed DMC

• 1 other identifier: #108.1_06092021
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Axial stability, cataract surgery, IOL, high myopia

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (4)

• Near and distance vision visual acuity

  6 months

• Patient's subjective satisfaction of with the quality of vision

  6 months

• Deviation from emmetropic refraction

  6 months

• Number of intra- and postoperative complications

  6 months

Study Arms (2)

IOL Clareon AutonoMe

EXPERIMENTAL

The first group of patients (39 eyes) who received the monofocal IOL Clareon AutonoMe after the phacoemulsification of cataract.

Procedure: IOL Clareon AutonoMe

IOL Hoya iSert 251

ACTIVE COMPARATOR

the second group of patients (39 eyes) who received the monofocal IOL Hoya iSert 251 after the phacoemulsification of cataract

Procedure: IOL Hoya iSert 251

Interventions

IOL Clareon AutonoMe PROCEDURE

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).

IOL Clareon AutonoMe

IOL Hoya iSert 251 PROCEDURE

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).

IOL Hoya iSert 251

Eligibility Criteria

• Age: 50 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• The S.N. Fyodorov Eye Microsurgery State Institution: lead
• Alcon Research: collaborator

Study Sites (1)

The S. N. Fyodorov Eye Microsurgery Federal State Institution

Moscow, 127486, Russia

Location

Related Publications (4)

• Wirtitsch MG, Findl O, Menapace R, Kriechbaum K, Koeppl C, Buehl W, Drexler W. Effect of haptic design on change in axial lens position after cataract surgery. J Cataract Refract Surg. 2004 Jan;30(1):45-51. doi: 10.1016/S0886-3350(03)00459-0.

  PMID: 14967267 BACKGROUND

• Remon L, Cabeza-Gil I, Calvo B, Poyales F, Garzon N. Biomechanical Stability of Three Intraocular Lenses With Different Haptic Designs: In Silico and In Vivo Evaluation. J Refract Surg. 2020 Sep 1;36(9):617-624. doi: 10.3928/1081597X-20200713-02.

  PMID: 32901830 BACKGROUND

• Bang S, Edell E, Yu Q, Pratzer K, Stark W. Accuracy of intraocular lens calculations using the IOLMaster in eyes with long axial length and a comparison of various formulas. Ophthalmology. 2011 Mar;118(3):503-6. doi: 10.1016/j.ophtha.2010.07.008. Epub 2010 Sep 29.

  PMID: 20884057 BACKGROUND

• Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019 Apr;45(4):501-506. doi: 10.1016/j.jcrs.2018.10.043. Epub 2019 Jan 25.

  PMID: 30686704 BACKGROUND

MeSH Terms

Conditions

Myopia; Astigmatism; Intraocular Lymphoma

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Eye Neoplasms; Neoplasms by Site; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Boris E Malyugin, MD, PhD

  The S. Fyodorov Eye Microsurgery Federal State Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first group of patients will receive the IOL Clareon AutonoMe (Alcon, USA), and the second group of patients will receive the IOL Hoya iSert 251 (Japan), 39 eyes in each group, total 78 patients, 78 eyes.

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 22, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 20, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: During the study and after.
• Access Criteria: upon request

Locations

RU (1)