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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Lens
• Intervention / Treatment: Device: Monofocal intraocular lens Clareon (Alcon LLC)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com
• Study Contact Backup: Name: Pavel Studeny, MD; Phone Number: +420775555342; Email: StudenyPavel@seznam.cz

Study Locations

• Czechia
  • Karlovy Vary, Czechia, 36001
    • Recruiting
    • Somich Eye Clinic
    • Contact: Pavel Studeny, MD; Phone Number: 775555342; Email: StudenyPavel@seznam.cz
  • Czech Republic
    • Prague, Czech Republic, Czechia, 11000
      • Recruiting
      • Eye Center Prague
      • Contact: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com
    • Prague, Czech Republic, Czechia, 11000
      • Recruiting
      • Faculty Hospital Královské Vinohrady
      • Contact: Andrea Janekova, MD; Phone Number: +420775727002; Email: janekovaandrea@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Monofocal lens; Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC)	Device: Monofocal intraocular lens Clareon (Alcon LLC); monofocal aspheric lens implanted in eyes of patient during routine cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular corrected Distance Visual Acuity (CDVA)	Monocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.	3 months
Binocular corrected Distance Visual Acuity (CDVA)	Binocular corrected distance visual acuity (CDVA) is measured at 4 m using an ETDRS (Early Treatment Diabetic Retinopathy Study) illumination cabinet (Precision Vision) under photopic conditions.	3 months
Monocular uncorrected intermediate visual acuity (UIVA)	Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months
Binocular uncorrected intermediate visual acuity (UIVA)	Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months
Monocular distance corrected intermediate visual acuity (DCIVA)	Monocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months
Binocular distance corrected intermediate visual acuity (DCIVA)	Binocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular defocus curve	A defocus curve that measures visual acuity should be obtained by using the best corrected distance refraction and then defocusing the image in 0.5 increments from +1.5 to -3.0 diopter with spherical plus and spherical minus trial lenses (i.e.,+1.5 D, +1.0 D, +0.5 D, 0.00 D, -0.5 D, -1.00 D, . . . ,-2.50 D) with visual acuity recorded at each change in correction.	3 months

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady
• Collaborators: Somich, s.r.o.; Očni centrum Praha a.s.
• Investigators: Principal Investigator: Andrea Janekova, MD, Eye Center Prague

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: January 15, 2023
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: intraocular lens; intermediate visual acuity; monofocal lens
• Other Study ID Numbers: CZ-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No