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

Intraocular Lens Clinical Trial

— CLAINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697978
• Other study ID #: CZ-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2023
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Andrea Janekova, MD
• Phone: +420775727002
• Email: janekovaandrea[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Intraocular Lens

Intervention

Device:
• Monofocal intraocular lens Clareon (Alcon LLC)
monofocal aspheric lens implanted in eyes of patient during routine cataract surgery

Locations

Country	Name	City	State
Czechia	Somich Eye Clinic	Karlovy Vary
Czechia	Eye Center Prague	Prague	Czech Republic
Czechia	Faculty hospital Kralovske Vinohrady	Prague	Czech Republic

Sponsors (3)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady	Ocni centrum Praha a.s., Somich, s.r.o.

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View Citation

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: 10.21 — View Citation

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(1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Monocular uncorrected intermediate visual acuity (UIVA)	Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months
Primary	Binocular uncorrected intermediate visual acuity (UIVA)	Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm	3 months
Primary	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
Primary	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	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