Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique
- Conditions
- AphakiaSecondary Cataract SurgeryComplicated Cataract Surgery
- Interventions
- Device: IOL Master 700Device: Casia-2Device: MS-39Device: OSIRISDevice: AutorefractorDiagnostic Test: Subjective RefractionDiagnostic Test: Biomicroscopy
- Registration Number
- NCT05912829
- Lead Sponsor
- Johannes Kepler University of Linz
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- best corrected visual acuity >0.1 (Snellen)
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kowa Group Biomicroscopy Patients who had a Kowa lens implanted using the Yamane technique Kowa Group IOL Master 700 Patients who had a Kowa lens implanted using the Yamane technique Kowa Group Casia-2 Patients who had a Kowa lens implanted using the Yamane technique Kowa Group Autorefractor Patients who had a Kowa lens implanted using the Yamane technique Johnson MS-39 Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Johnson Autorefractor Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Kowa Group MS-39 Patients who had a Kowa lens implanted using the Yamane technique Johnson Casia-2 Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Johnson OSIRIS Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Kowa Group OSIRIS Patients who had a Kowa lens implanted using the Yamane technique Kowa Group Subjective Refraction Patients who had a Kowa lens implanted using the Yamane technique Johnson IOL Master 700 Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Johnson Subjective Refraction Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique Johnson Biomicroscopy Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique
- Primary Outcome Measures
Name Time Method Best corrected visual acuity 6 Weeks Measurement performed by experienced staff
uncorrected visual acuity 6 Weeks Measurement performed by experienced staff
Tilt 6 Weeks Postoperative Tilt
Autorefraction 6 Weeks Refraction using an automated refractor
Subjective Refraction 6 Weeks Refraction performed by experienced staff
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
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