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| Name | Class |
|---|---|
| Očni centrum Praha a.s. | UNKNOWN |
| Somich, s.r.o. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofocal lens | Other | Eyes of patients with implanted monofocal aspheric lens Clareon (Alcon LLC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofocal intraocular lens Clareon (Alcon LLC) | Device | monofocal aspheric lens implanted in eyes of patient during routine cataract surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Janekova, MD | Contact | +420775727002 | janekovaandrea@gmail.com | |
| Pavel Studeny, MD | Contact | +420775555342 | StudenyPavel@seznam.cz |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Janekova, MD | Eye Center Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center Prague | Recruiting | Prague | Czech Republic | 11000 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33907378 | Result | 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. | |
| 31399323 | 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. |
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each patient in group received monofocal intraocular lens in both eyes
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no masking
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| Faculty hospital Kralovske Vinohrady | Recruiting | Prague | Czech Republic | 11000 | Czechia |
|
| Somich Eye Clinic | Recruiting | Karlovy Vary | 36001 | Czechia |
|
| 34288635 | 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. |