Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

Aphakia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912829
• Other study ID #: KUK-Ophthalmology-012
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: May 2025

Study information

• Verified date: October 2023
• Source: Johannes Kepler University of Linz
• Contact: Christina Silber, MSc
• Phone: +43 5 7680 83
• Email: christina.silber[@]kepleruniklinikum.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphakia
• Capsule Opacification
• Cataract

Intervention

Device:
• IOL Master 700
Biometry using the IOL Master 700
• Casia-2
Anterior segment-OCT to evaluate lens tilt
• MS-39
Corneal Topography using the MS-39
• OSIRIS
Abberometry using the OSIRIS-Abberometer
• Autorefractor
Evaluation of Refraction using an Autorefractor

Diagnostic Test:
• Subjective Refraction
Refraction performed by experienced staff
• Biomicroscopy
Slit Lamp Examination

Locations

Country	Name	City	State
Austria	Department for Ophthalmology and Optometry	Linz	Upper Austria
Austria	Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Kepler University of Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tilt	Postoperative Tilt	6 Weeks
Primary	Autorefraction	Refraction using an automated refractor	6 Weeks
Primary	Subjective Refraction	Refraction performed by experienced staff	6 Weeks
Primary	Best corrected visual acuity	Measurement performed by experienced staff	6 Weeks
Primary	uncorrected visual acuity	Measurement performed by experienced staff	6 Weeks