Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique
NCT ID: NCT05912829
Last Updated: 2023-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2023-06-01
2025-05-31
Brief Summary
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Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation.
The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.
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Detailed Description
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The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles.
Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson\&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability.
All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Kowa Group
Patients who had a Kowa lens implanted using the Yamane technique
IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Biomicroscopy
Slit Lamp Examination
Johnson
Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique
IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Biomicroscopy
Slit Lamp Examination
Interventions
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IOL Master 700
Biometry using the IOL Master 700
Casia-2
Anterior segment-OCT to evaluate lens tilt
MS-39
Corneal Topography using the MS-39
OSIRIS
Abberometry using the OSIRIS-Abberometer
Autorefractor
Evaluation of Refraction using an Autorefractor
Subjective Refraction
Refraction performed by experienced staff
Biomicroscopy
Slit Lamp Examination
Eligibility Criteria
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Inclusion Criteria
* planned or performed lens implantation using the Kowa PU6AS or the Johnson \& Johnson ZA9003 using the Yamane technique
* signed patient consent form
Exclusion Criteria
* pregnancy
21 Years
110 Years
ALL
No
Sponsors
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Johannes Kepler University of Linz
OTHER
Responsible Party
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Principal Investigators
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Matthias Bolz, MD
Role: STUDY_CHAIR
JKU Linz
Locations
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Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz
Linz, Upper Austria, Austria
Department for Ophthalmology and Optometry
Linz, Upper Austria, Austria
Countries
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Central Contacts
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Facility Contacts
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Kepler University Hospital GmbH, Johannes Kepler University
Role: primary
Other Identifiers
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KUK-Ophthalmology-012
Identifier Type: -
Identifier Source: org_study_id
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