Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aphakia; Secondary Cataract Surgery; Complicated Cataract Surgery
• Intervention / Treatment: Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic test: Subjective Refraction; Diagnostic test: Biomicroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Christina Silber, MSc; Phone Number: 1944 +43 5 7680 83; Email: christina.silber@kepleruniklinikum.at
• Study Contact Backup: Name: Nino Hirnschall, MD; Phone Number: 73425 +43 5 7680 83; Email: nino.hirnschall@kepleruniklinikum.at

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz
      • Sub-Investigator: Nino Hirnschall, MD
      • Contact: Christina Silber, MSc; Phone Number: +4357680831944; Email: christina.silber@kepleruniklinikum.at
      • Contact: Nino Hirnschall, MD; Phone Number: 73425 +435768083; Email: nino.hirnschall@kepleruniklinikum.at
      • Principal Investigator: Matthias Bolz, MD
      • Sub-Investigator: Marina Casazza, MD
      • Sub-Investigator: Jan Rothbächer, MD
      • Sub-Investigator: Sophia Reifeltshammer, BSc
      • Sub-Investigator: Leon Pomberger, MD
      • Sub-Investigator: Klemens Waser, MD
      • Sub-Investigator: Siegfried Mariacher, MD
      • Sub-Investigator: Haidar Khalil, MD
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Department for Ophthalmology and Optometry
      • Sub-Investigator: Sophia Reifeltshammer, BSc
      • Contact: Kepler University Hospital GmbH, Johannes Kepler University; Phone Number: +43 5 7680 83 1944; Email: christina.silber@kepleruniklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Only patients who are undergoing (underwent)routine secondary cataract surgery will be included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz
• Investigators: Study Chair: Matthias Bolz, MD, JKU Linz

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Aphakia; Capsule Opacification
• Other Study ID Numbers: KUK-Ophthalmology-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No