Yamane IOL Evaluation
Study Details
Study Description
Brief Summary
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 intrascentrally 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kowa Group Patients who had a Kowa lens implanted using the Yamane technique |
Device: IOL Master 700
Biometry using the IOL Master 700
Device: Casia-2
Anterior segment-OCT to evaluate lens tilt
Device: MS-39
Corneal Topography using the MS-39
Device: OSIRIS
Abberometry using the OSIRIS-Abberometer
Device: Autorefractor
Evaluation of Refraction using an Autorefractor
Diagnostic Test: Subjective Refraction
Refraction performed by experienced staff
Diagnostic Test: Biomicroscopy
Slit Lamp Examination
|
| Johnson Patients who had the ZA9003 (J&J) lens implanted using the Yamane technique |
Device: IOL Master 700
Biometry using the IOL Master 700
Device: Casia-2
Anterior segment-OCT to evaluate lens tilt
Device: MS-39
Corneal Topography using the MS-39
Device: OSIRIS
Abberometry using the OSIRIS-Abberometer
Device: Autorefractor
Evaluation of Refraction using an Autorefractor
Diagnostic Test: Subjective Refraction
Refraction performed by experienced staff
Diagnostic Test: Biomicroscopy
Slit Lamp Examination
|
Outcome Measures
Primary Outcome Measures
- Tilt [6 Weeks]
Postoperative Tilt
- Autorefraction [6 Weeks]
Refraction using an automated refractor
- Subjective Refraction [6 Weeks]
Refraction performed by experienced staff
- Best corrected visual acuity [6 Weeks]
Measurement performed by experienced staff
- uncorrected visual acuity [6 Weeks]
Measurement performed by experienced staff
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz | Linz | Upper Austria | Austria | 4020 |
| 2 | Department for Ophthalmology and Optometry | Linz | Upper Austria | Austria | 4020 |
Sponsors and Collaborators
- Johannes Kepler University of Linz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KUK-Ophthalmology-012