Performance of Two Sclera Fixated Intraocular Lens Concepts

Study Overview
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Brief Summary
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To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

Detailed Description
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Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years. The popular Yamane technique or flanged IOL fixation uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt. A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation. However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, 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 management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment. The collected data is then evaluated and analyzed as well as compared to the Yamane data.

Official Title
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Performance of Two Sclera Fixated Intraocular Lens Concepts

Conditions
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Cataract Complicated, Cataract Complications Operations

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimum age of 21 years planned surgery or already taken place surgery using a scleral fixated lens Exclusion Criteria: best corrected visual acuity <0.05 Snellen pregnancy missing informed consent form

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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carlevale<br>Patients who had a Carlevale lens implanted | 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>|
| Yamane<br>Patients who had a lens implanted using 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>|

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 |