Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens

NCT ID: NCT05697978

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-08-01

Brief Summary

To get the visual outcomes for distance and intermediate and binocular defocus curve in patients with implanted monofocal intraocular lens Clareon (IOL; model SY60CL; Alcon Vision LLC) at 3 months after the surgery.

Detailed Description

The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a monofocal IOL. This, however, does not offer much in the way of intermediate and near vision. The increased desire for simultaneous distance, intermediate and near vision has increased the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all distances, they has occurence of optical phenomena such as glare and halo and lower contrast sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as monofocal lens and intermediate vision better than monofocal but without or with less appearance of optical phenomenon or decreased contrast sensitivity.

This study is prospective, multi-center, conducted from 10/2022 to 08/2023 in the Ophthalmology department of Faculty Hospital Kralovske Vinohrady in Prague, in Eye Center Prague and Eye Clinic SOMICH (Karlovy Vary). The research protocol was explained to all participants and informed consent was signed before enrolling patient to the study. The study was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will enrolled up to 100 patients with presence of cataract in both eyes.

Bilateral clear corneal phacoemulsification and IOL implantation is performed by two experienced surgeon using the same technique in both eyes. The surgical process involved topical anesthesia, superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis, phacoemulsification, bilateral irrigation- aspiration and implantation of monofocal aspheric intraocular lens (Clareon Alcon vision LLC).

Patients are scheduled for visit at 3 months after the surgery.

Conditions

Intraocular Lens

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monofocal lens

Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC)

Group Type: OTHER

Monofocal intraocular lens Clareon (Alcon LLC)

Intervention Type: DEVICE

monofocal aspheric lens implanted in eyes of patient during routine cataract surgery

Interventions

Monofocal intraocular lens Clareon (Alcon LLC)

monofocal aspheric lens implanted in eyes of patient during routine cataract surgery

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• presence of cataract in both eyes
• no other ocular pathology affecting visual acuity
• bilateral phacoemulsification cataract surgery was arranged for both eyes
• corneal astigmatism up to 0,5 cylinder (measured by IOL Master biometry)
• dioptric power of both selective lens within 1,5 D range in one patient
• selecting IOL power between 15 D and 28 D power range

Exclusion Criteria

• complicated cataract
• corneal opacities or irregularities
• amblyopia
• anisometropia
• coexisting ocular pathologies
• glaucoma
• history of ocular surgery
• refusal or unable to maintain follow-up

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Očni centrum Praha a.s.

UNKNOWN

Sponsor Role: collaborator

Somich, s.r.o.

OTHER

Sponsor Role: collaborator

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andrea Janekova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Janekova, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Center Prague

Locations

Eye Center Prague

Prague, Czech Republic, Czechia

Site Status: RECRUITING

Faculty hospital Kralovske Vinohrady

Prague, Czech Republic, Czechia

Site Status: RECRUITING

Somich Eye Clinic

Karlovy Vary, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Andrea Janekova, MD

Role: CONTACT

janekovaandrea@gmail.com

+420775727002

Pavel Studeny, MD

Role: CONTACT

StudenyPavel@seznam.cz

+420775555342

Facility Contacts

Andrea Janekova, MD

Role: primary

janekovaandrea@gmail.com

+420775727002

Andrea Janekova, MD

Role: primary

janekovaandrea@gmail.com

+420775727002

Pavel Studeny, MD

Role: primary

StudenyPavel@seznam.cz

775555342

References

Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021 Apr 20;15:1647-1657. doi: 10.2147/OPTH.S295008. eCollection 2021.

Reference Type: RESULT

PMID: 33907378 (View on PubMed)

Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Canones-Zafra R, Teus MA. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019 Oct;45(10):1490-1497. doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6.

Reference Type: RESULT

PMID: 31399323 (View on PubMed)

Bala C, Poyales F, Guarro M, Mesa RR, Mearza A, Varma DK, Jasti S, Lemp-Hull J. Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL. J Cataract Refract Surg. 2022 Feb 1;48(2):136-143. doi: 10.1097/j.jcrs.0000000000000712.

Reference Type: RESULT

PMID: 34288635 (View on PubMed)

Other Identifiers

CZ-001

Identifier Type: -

Identifier Source: org_study_id