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

NCT05697978 | Unknown

• 1 other identifier: CZ-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Intraocular Lens

Keywords

intraocular lens; monofocal lens; intermediate visual acuity

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Binocular defocus curve

  3 months

Study Arms (1)

Monofocal lens

OTHER

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

Device: Monofocal intraocular lens Clareon (Alcon LLC)

Interventions

Monofocal intraocular lens Clareon (Alcon LLC) DEVICE

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

Monofocal lens

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead
• Očni centrum Praha a.s.: collaborator
• Somich, s.r.o.: collaborator

Study Sites (3)

Eye Center Prague

Prague, Czech Republic, 11000, Czechia

RECRUITING

Faculty hospital Kralovske Vinohrady

Prague, Czech Republic, 11000, Czechia

RECRUITING

Somich Eye Clinic

Karlovy Vary, 36001, Czechia

RECRUITING

Related Publications (3)

• 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.

  PMID: 33907378 RESULT

• 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.

  PMID: 31399323 RESULT

• 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.

  PMID: 34288635 RESULT

Study Officials

• Andrea Janekova, MD

  Eye Center Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Janekova, MD

CONTACT

+420775727002; janekovaandrea@gmail.com

Pavel Studeny, MD

CONTACT

+420775555342; StudenyPavel@seznam.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: each patient in group received monofocal intraocular lens in both eyes

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: January 26, 2023
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)