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RecruitingNCT05912829Updated Oct 5, 2023

Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique

An observational study in Secondary Cataract Surgery, Aphakia and Complicated Cataract Surgery, sponsored by Johannes Kepler University of Linz. Recruiting at 2 sites in Austria. Open to participants aged 21 Years to 110 Years. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Johannes Kepler University of Linz · Observational

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
21 Years to 110 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Secondary Cataract Surgery
  • Aphakia
  • Complicated Cataract Surgery

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03

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's planned enrollment of 50 is below the median of 95 across 15 observational studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

Johannes Kepler University of Linz is the lead sponsor of 33 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 110 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • best corrected visual acuity >0.1 (Snellen)
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
6 Weeks
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceIOL Master 700

    Biometry using the IOL Master 700

  • DeviceCasia-2

    Anterior segment-OCT to evaluate lens tilt

  • DeviceMS-39

    Corneal Topography using the MS-39

  • DeviceOSIRIS

    Abberometry using the OSIRIS-Abberometer

  • DeviceAutorefractor

    Evaluation of Refraction using an Autorefractor

  • Diagnostic testSubjective Refraction

    Refraction performed by experienced staff

  • Diagnostic testBiomicroscopy

    Slit Lamp Examination

06

What researchers measure

Primary outcomes

  1. Tilt

    Postoperative Tilt

    Time frame: 6 Weeks

  2. Autorefraction

    Refraction using an automated refractor

    Time frame: 6 Weeks

  3. Subjective Refraction

    Refraction performed by experienced staff

    Time frame: 6 Weeks

  4. Best corrected visual acuity

    Measurement performed by experienced staff

    Time frame: 6 Weeks

  5. uncorrected visual acuity

    Measurement performed by experienced staff

    Time frame: 6 Weeks

07

Study locations

2 of 2 sites recruiting
  • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz
    Linz, Upper Austria 4020, Austria
    Recruiting
    • Christina Silber, MSc · Contactchristina.silber@kepleruniklinikum.at · +4357680831944
    • Nino Hirnschall, MD · Contactnino.hirnschall@kepleruniklinikum.at · +435768083
    • Matthias Bolz, MD · Principal investigator
    • Marina Casazza, MD · Sub investigator
    • Nino Hirnschall, 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 · Sub investigator
  • Department for Ophthalmology and Optometry
    Linz, Upper Austria 4020, Austria
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2023 (actual). Primary completion is estimated for May 2024, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2023
First posted
Jun 22, 2023
StartActual
Jun 1, 2023
Primary completionEst.
May 2024
CompletionEst.
May 2025
Last update
Oct 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05912829
Lead sponsor
Johannes Kepler University of Linz
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
Jun 1, 2023
Primary completion
May 2024 (estimated)
Completion
May 2025 (estimated)
Last update
Oct 5, 2023

Study contacts

Christina Silber, MSc
Contact
christina.silber@kepleruniklinikum.at
+43 5 7680 83 ext. 1944
Nino Hirnschall, MD
Contact
nino.hirnschall@kepleruniklinikum.at
+43 5 7680 83 ext. 73425
Matthias Bolz, MD
study chair · JKU Linz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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