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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kowa Group | Patients who had a Kowa lens implanted using the Yamane technique |
| |
| Johnson | Patients who had the ZA9003 (J&J) lens implanted using the Yamane technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL Master 700 | Device | Biometry using the IOL Master 700 |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Only patients who are undergoing (underwent)routine secondary cataract surgery will be included in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Silber, MSc | Contact | +43 5 7680 83 | 1944 | christina.silber@kepleruniklinikum.at |
| Nino Hirnschall, MD | Contact | +43 5 7680 83 | 73425 | nino.hirnschall@kepleruniklinikum.at |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Bolz, MD | JKU Linz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz | Recruiting | Linz | Upper Austria | 4020 | Austria |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D033401 | Microscopy, Acoustic |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Casia-2 |
| Device |
Anterior segment-OCT to evaluate lens tilt |
|
| MS-39 | Device | Corneal Topography using the MS-39 |
|
| OSIRIS | Device | Abberometry using the OSIRIS-Abberometer |
|
| Autorefractor | Device | Evaluation of Refraction using an Autorefractor |
|
| Subjective Refraction | Diagnostic Test | Refraction performed by experienced staff |
|
| Biomicroscopy | Diagnostic Test | Slit Lamp Examination |
|
| Department for Ophthalmology and Optometry | Recruiting | Linz | Upper Austria | 4020 | Austria |
|
| D014463 |
| Ultrasonography |
| D008919 | Investigative Techniques |