Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

Study Overview
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Brief Summary
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In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel. 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.

Detailed Description
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During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method. 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.

Official Title
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Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique

Conditions
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Secondary Cataract Surgery, Aphakia, Complicated Cataract Surgery

Intervention / Treatment
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* Device: IOL Master 700
* Device: Casia-2
* Device: MS-39
* Device: OSIRIS
* Device: Autorefractor
* Diagnostic Test: Subjective Refraction
* Diagnostic Test: Biomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age: 21 Years planned or performed lens implantation using the Kowa PU6AS or the Johnson & Johnson ZA9003 using the Yamane technique signed patient consent form Exclusion Criteria: best corrected visual acuity >0.1 (Snellen) pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kowa Group<br>Patients who had a Kowa lens implanted using the Yamane technique | Device: IOL Master 700<br>* Biometry using the IOL Master 700<br>Device: Casia-2<br>* Anterior segment-OCT to evaluate lens tilt<br>Device: MS-39<br>* Corneal Topography using the MS-39<br>Device: OSIRIS<br>* Abberometry using the OSIRIS-Abberometer<br>Device: Autorefractor<br>* Evaluation of Refraction using an Autorefractor<br>Diagnostic Test: Subjective Refraction<br>* Refraction performed by experienced staff<br>Diagnostic Test: Biomicroscopy<br>* Slit Lamp Examination<br>|
| Johnson<br>Patients who had the ZA9003 (J&J) lens implanted using the Yamane technique | Device: IOL Master 700<br>* Biometry using the IOL Master 700<br>Device: Casia-2<br>* Anterior segment-OCT to evaluate lens tilt<br>Device: MS-39<br>* Corneal Topography using the MS-39<br>Device: OSIRIS<br>* Abberometry using the OSIRIS-Abberometer<br>Device: Autorefractor<br>* Evaluation of Refraction using an Autorefractor<br>Diagnostic Test: Subjective Refraction<br>* Refraction performed by experienced staff<br>Diagnostic Test: Biomicroscopy<br>* Slit Lamp Examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tilt | Postoperative Tilt | 6 Weeks | 
| Autorefraction | Refraction using an automated refractor | 6 Weeks | 
| Subjective Refraction | Refraction performed by experienced staff | 6 Weeks | 
| Best corrected visual acuity | Measurement performed by experienced staff | 6 Weeks | 
| uncorrected visual acuity | Measurement performed by experienced staff | 6 Weeks |