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

Primary Purpose

Cataract Senile, Myopia, High-Grade, Corneal Astigmatism

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

IOL Clareon AutonoMe

IOL Hoya iSert 251

About this trial

This is an interventional treatment trial for Cataract Senile focused on measuring Axial stability, cataract surgery, IOL, high myopia

Eligibility Criteria

50 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.)
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 (for example, patients from other cities).
Suspected drug or alcohol abuse.

Sites / Locations

The S. N. Fyodorov Eye Microsurgery Federal State InstitutionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL Clareon AutonoMe

IOL Hoya iSert 251

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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).

Deviation from emmetropic refraction

Accurate IOL calculation before surgery.

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.

Full Information

NCT ID

NCT05129566

First Posted

November 10, 2021

Last Updated

November 24, 2021

Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Collaborators

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT05129566

Brief Title

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

Official Title

Comparative Evaluation of Long-term Axial Stability of Two Different Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The S.N. Fyodorov Eye Microsurgery State Institution

Collaborators

Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract Senile, Myopia, High-Grade, Corneal Astigmatism

Keywords

Axial stability, cataract surgery, IOL, high myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IOL Clareon AutonoMe

Arm Type

Experimental

Arm Description

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

Arm Title

IOL Hoya iSert 251

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

IOL Clareon AutonoMe

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

IOL Hoya iSert 251

Intervention Description

Primary Outcome Measure Information:

Title

Intraocular lens axial displacement

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Near and distance vision visual acuity

Description

Time Frame

6 months

Title

Patient's subjective satisfaction of with the quality of vision

Description

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

Title

Deviation from emmetropic refraction

Description

Accurate IOL calculation before surgery.

Time Frame

6 months

Title

Number of intra- and postoperative complications

Description

Intra- and postoperative complications in the operated eye will be assessed according to the observation data of the research subjects.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.) 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 (for example, patients from other cities). Suspected drug or alcohol abuse.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Olga V Fomina, MD, PhD

Phone

+79855172351

fomina.ov.ophthalmologist@mail.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Alexander A Shpak, MD, PhD

Phone

+7 (916) 173-44-69

a_shpak@inbox.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boris E Malyugin, MD, PhD

Organizational Affiliation

The S. Fyodorov Eye Microsurgery Federal State Institution

Official's Role

Principal Investigator

Facility Information:

Facility Name

The S. N. Fyodorov Eye Microsurgery Federal State Institution

City

Moscow

ZIP/Postal Code

127486

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boris E Malyugin, MD, PhD

Phone

+7 (499) 488-85-11

boris.malyugin@gmail.com

First Name & Middle Initial & Last Name & Degree

Alexander A Shpak, MD, PhD

Phone

+7 (916) 173-44-69

a_shpak@inbox.ru

First Name & Middle Initial & Last Name & Degree

Boris E Malyugin, MD, PhD

First Name & Middle Initial & Last Name & Degree

Alexander A Shpak, MD, PhD

First Name & Middle Initial & Last Name & Degree

Olga V Fomina, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We plan to share Clinical Study Report, present and publish results of the study.

IPD Sharing Time Frame

During the study and after.

IPD Sharing Access Criteria

upon request

Citations:

PubMed Identifier

14967267

Citation

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.

Results Reference

background

PubMed Identifier

32901830

Citation

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.

Results Reference

background

PubMed Identifier

20884057

Citation

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.

Results Reference

background

PubMed Identifier

30686704

Citation

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.

Results Reference

background

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

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