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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraocular Lens

Intervention / Treatment
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* Device: Monofocal intraocular lens Clareon (Alcon LLC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: each patient in group received monofocal intraocular lens in both eyes
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular lens, monofocal lens, intermediate visual acuity