Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

NCT05912829 | Unknown

• 1 other identifier: KUK-Ophthalmology-012
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Secondary Cataract Surgery; Aphakia; Complicated Cataract Surgery

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Kowa Group

Patients who had a Kowa lens implanted using the Yamane technique

Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic Test: Subjective Refraction; Diagnostic Test: Biomicroscopy

Johnson

Patients who had the ZA9003 (J\&J) lens implanted using the Yamane technique

Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic Test: Subjective Refraction; Diagnostic Test: Biomicroscopy

Interventions

IOL Master 700 DEVICE

Biometry using the IOL Master 700

Johnson; Kowa Group

Casia-2 DEVICE

Anterior segment-OCT to evaluate lens tilt

Johnson; Kowa Group

MS-39 DEVICE

Corneal Topography using the MS-39

Johnson; Kowa Group

OSIRIS DEVICE

Abberometry using the OSIRIS-Abberometer

Johnson; Kowa Group

Autorefractor DEVICE

Evaluation of Refraction using an Autorefractor

Johnson; Kowa Group

Subjective Refraction DIAGNOSTIC_TEST

Refraction performed by experienced staff

Johnson; Kowa Group

Biomicroscopy DIAGNOSTIC_TEST

Slit Lamp Examination

Johnson; Kowa Group

Eligibility Criteria

• Age: 21 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• best corrected visual acuity \>0.1 (Snellen)
• pregnancy

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (2)

Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz

Linz, Upper Austria, 4020, Austria

RECRUITING

Department for Ophthalmology and Optometry

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Aphakia

Interventions

Microscopy, Acoustic

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Investigative Techniques

Study Officials

• Matthias Bolz, MD

  JKU Linz

  STUDY CHAIR

Central Study Contacts

Christina Silber, MSc

CONTACT

+43 5 7680 83; christina.silber@kepleruniklinikum.at

Nino Hirnschall, MD

CONTACT

+43 5 7680 83; nino.hirnschall@kepleruniklinikum.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)