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

Not Applicable

Recruiting

• Conditions: Intraocular Lens
• Interventions: Device: Monofocal intraocular lens Clareon (Alcon LLC)

• Registration Number: NCT05697978
• Lead Sponsor: Faculty Hospital Kralovske Vinohrady

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2023-01-15
• Study First Submitted QC: 2023-01-15
• Study First Posted: 2023-01-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23
• Primary Completion: 2023-05-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monofocal lens	Monofocal intraocular lens Clareon (Alcon LLC)	Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC)

Primary Outcome Measures

Name	Time	Method
Monocular corrected Distance Visual Acuity (CDVA)	3 months	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.
Binocular corrected Distance Visual Acuity (CDVA)	3 months	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.
Monocular distance corrected intermediate visual acuity (DCIVA)	3 months	Monocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Binocular uncorrected intermediate visual acuity (UIVA)	3 months	Binocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Binocular distance corrected intermediate visual acuity (DCIVA)	3 months	Binocular distance corrected intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm
Monocular uncorrected intermediate visual acuity (UIVA)	3 months	Monocular intermediate visual acuity is measured using printed ETDRS charts for distance of 66cm

Secondary Outcome Measures

Name	Time	Method
Binocular defocus curve	3 months	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.

Trial Locations

Locations (3)

Somich Eye Clinic; 🇨🇿 Karlovy Vary, Czechia

Faculty hospital Kralovske Vinohrady; 🇨🇿 Prague, Czech Republic, Czechia

Eye Center Prague; 🇨🇿 Prague, Czech Republic, Czechia