Clinical trial NCT05697978: Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens
Official title: Distance and Intermediate Visual Acuity in Patients With Implanted Monofocal Negative Aspheric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Lens
Keywords: intraocular lens
monofocal lens
intermediate visual acuity
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
Collaborators: name: Očni centrum Praha a.s.
name: Somich, s.r.o.
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: each patient in group received monofocal intraocular lens in both eyes
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Monocular corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months
measure: Binocular corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months
measure: Monocular uncorrected intermediate visual acuity (UIVA)
timeFrame: 3 months
measure: Binocular uncorrected intermediate visual acuity (UIVA)
timeFrame: 3 months
measure: Monocular distance corrected intermediate visual acuity (DCIVA)
timeFrame: 3 months
measure: Binocular distance corrected intermediate visual acuity (DCIVA)
timeFrame: 3 months
Secondary outcomes:
measure: Binocular defocus curve
timeFrame: 3 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Eye Center Prague
state: Czech Republic
city: Prague
country: Czechia
facility: Faculty hospital Kralovske Vinohrady
state: Czech Republic
city: Karlovy Vary
country: Czechia
facility: Somich Eye Clinic
Study officials:
affiliation: Eye Center Prague
name: Andrea Janekova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.2147/OPTH.S295008. eCollection 2021.
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(10):1490-1497. doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6.
citation: 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.