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- Klinische proef NCT05194657
Reading Performance in Patients With Acrysof IQ Vivity Versus Acrysof IQ
Assessment of Reading Performance in Patients With Acrysof IQ Vivity Toric or Non-toric vs Monofocal Acrysof IQ Toric or Non-toric IOL
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
With increasing demands of patients concerning their visual function after cataract surgery, a variety of advanced technology intraocular lenses (IOL) have become available in the last years. Various developments aim at a reduced spectacle independence for patients after cataract or refractive lens surgery.
Novel technology for providing an extended depth of focus (EDOF) has been developed to account for unmet needs of patients. A novel EDOF IOL, the Acrysof IQ Vivity, has two surface transition elements that work simultaneously by stretching and shifting the wavefront to create a continuous extended focal range instead of multiple focal points.
To assess the performance of such an IOL technology, most studies assess visual acuity at different distances from far, to intermediate up to near. Since most activites with digital devices implicate reading, it is not surprising that reading difficulty is the most common complaint among individuals experiencing visual disturbances with multifocal designs.
Reading ability is usually evaluated using various reading tests that assess reading speed and reading acuity defined as the print size that can stell be read with sufficient speed. However, one of the fundamental problems of these tests is that reading speed is also influenced by the average amount of time that a patient reads as well as the language of the text, whether it is the first or second language.
A novel method to analyse reading performance that appears to be more objective and less reliant on the cognitive abilities of the patient is the observation of the reading pattern using a high-speed eye-tracking system that analyses eye fixations during the reading test. In previous studies we have seen that several aspects of this reading patter, i.e. fixation duration and fixation frequency, appear to correlate with the reading performance overall and can be differentially used to discriminate between cognitive and visuo-motor processing.
Hence, the aim of this study is to assess the visual function and reading performance with an EDOF IOL (Acrysof IQ Vivity) compared to a standard monofocal IOL (Acrysof IQ).
136 eyes of 68 patients will be included into this study. According to the randomization, 34 patients will be implanted with the Acrysof IQ Vivity in both eyes and the other 34 patients will be implanted with the Acrysof IQ in both eyes. A follow-up examination will be performed at 3 months postoperative. During this visit a slitlamp examination, biometry and tomography of the eye, refraction and visual acuity assessment, an OCT examination, a retroillumination photogrypha, reading speed analysis and halometry will be performed.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Natascha Bayer, MSc
- Telefoonnummer: 57564 01 91021
- E-mail: office@viros.at
Studie Contact Back-up
- Naam: Sahand Amir-Asgari, MD
- Telefoonnummer: 57564 01 91021
- E-mail: office@viros.at
Studie Locaties
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Vienna, Oostenrijk, 1140
- Werving
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
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Contact:
- Natascha Bayer, MSc
- Telefoonnummer: 57564 01 91021
- E-mail: office@viros.at
-
Contact:
- Sahand Amir-Asgari, MD
- Telefoonnummer: 57564 01 91021
- E-mail: office@viros.at
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Cataract
- Stereopsis
- age 21 and older
- regular corneal astigmatism of up to 3.0 D
- written informed consent prior to surgery
- normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- availability, willingness and sufficient cognitive awareness to comply with examination procedures
- german as mother-tongue
- calculated IOL power needed is below 15.0 D or above 25.0 D (no high myopia or high hypermetropia will be recruited)
Exclusion Criteria:
- relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract, corneal scars, and other co-morbidity that could affect capsule bag stability (e.g. Marfan syndrome) or retinal diseases affecting visual acuity (AMD, Macular Pucker, post-operative macular edema...)
- amblyopia
- contact lenses
- irregular corneal astigmatism on corneal topography
- postoperative subjective refraction smaller/ higher than or 0.75 D
- pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Acrysof IQ Vivity
Patient will receive the enhanced depth of focus IOL during cataract surgery
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Acrysof IQ Vivity, enhanced depth of focus IOL
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Experimenteel: Acrysof IQ
Patiet will receive the monofocal IOL during cataract surgery
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Acrysof IQ, monofocal IOL
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Reading speed
Tijdsspanne: 24 months
|
reading speed will be assessed with the Eyetracker device at 66 centimetres and will be compared between the EDOF IOL and the monofocal IOL
|
24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Visual acuity
Tijdsspanne: 24 months
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Visual acuity will be assessed using the ETDRS charts and will be compared between the EDOF IOLs and the monofocal IOLs
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24 months
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Vivity
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Staar
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Fundación Pública Andaluza para la Investigación...VoltooidStaar | Cataract volwassen | Cataract, nucleair
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Johannes Kepler University of LinzVoltooidCataract ingewikkeld | Cataract Complicaties OperatiesOostenrijk
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Gemini Eye ClinicWervingBilaterale cataract | Eenzijdige cataractTsjechië
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Alterman, Modi, & Wolter Ophthalmic Physicians...VoltooidStaar | Astigmatisme | Corticaal cataract | Nucleaire sclerose | Achterste subcapsulaire cataractVerenigde Staten
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Nicole Fram M.D.VoltooidCataract Seniel | Ontsteking van de voorste kamer | Oculaire pijn | Hoornvlies oedeem | Hoornvlies defect | Doordringende KeratoPlasty | Nucleaire cataract | Corticaal cataractVerenigde Staten
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Steve H. Linn, ODVoltooidCorticaal cataract | Achterste subcapsulaire cataract | Nucleaire sclerose van de lensVerenigde Staten
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Advanced Center for Eyecare GlobalNog niet aan het werven
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University Hospital, ToursWervingLeeftijdsgebonden cataractFrankrijk
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Vienna Institute for Research in Ocular SurgeryWerving
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Zhongshan Ophthalmic Center, Sun Yat-sen UniversityNog niet aan het werven