Secondary Cataract SurgeryNCT05912829
Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique
An observational study of Secondary Cataract Surgery and Aphakia, run by Johannes Kepler University of Linz at 2 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Secondary Cataract Surgery, Aphakia, Complicated Cataract Surgery
- What is being tested?
- IOL Master 700, Casia-2 and MS-39
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Jun 2023to May 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients who are undergoing (underwent)routine secondary cataract surgery will be included in this study.
Who may be able to join
- 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
Who cannot join
- best corrected visual acuity >0.1 (Snellen)
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz
Linz, Upper Austria, 4020
Christina Silber, MSc, +4357680831944, christina.silber@kepleruniklinikum.at
Nino Hirnschall, MD, +435768083 ext. 73425, nino.hirnschall@kepleruniklinikum.at
- Recruiting
Department for Ophthalmology and Optometry
Linz, Upper Austria, 4020
Kepler University Hospital GmbH, Johannes Kepler University, +43 5 7680 83 1944, christina.silber@kepleruniklinikum.at
Sophia Reifeltshammer, BSc
About this study
Official title: 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.
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.
- Being tested
- IOL Master 700, Casia-2, MS-39, OSIRIS, Autorefractor
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL Master 700Device
Biometry using the IOL Master 700
Casia-2Device
Anterior segment-OCT to evaluate lens tilt
MS-39Device
Corneal Topography using the MS-39
OSIRISDevice
Abberometry using the OSIRIS-Abberometer
AutorefractorDevice
Evaluation of Refraction using an Autorefractor
Subjective RefractionDiagnostic test
Refraction performed by experienced staff
BiomicroscopyDiagnostic test
Slit Lamp Examination
| Study group | Role | What they receive |
|---|---|---|
| Kowa Group | Patients who had a Kowa lens implanted using the Yamane technique Receives: 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 Receives: Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic Test: Subjective Refraction; Diagnostic Test: Biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilt
Postoperative Tilt
Measured: 6 Weeks
Autorefraction
Refraction using an automated refractor
Measured: 6 Weeks
Subjective Refraction
Refraction performed by experienced staff
Measured: 6 Weeks
Best corrected visual acuity
Measurement performed by experienced staff
Measured: 6 Weeks
uncorrected visual acuity
Measurement performed by experienced staff
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2023
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Bolz, MD, Study chair, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912829
- Sponsor's protocol ID
- KUK-Ophthalmology-012
- Status last verified
- Oct 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique
- ClinicalTrials.gov ID
- NCT05912829
- Acronym / sponsor ID
- KUK-Ophthalmology-012
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kowa Group | – | Device: IOL Master 700, Device: Casia-2, Device: MS-39, Device: OSIRIS, Device: Autorefractor, Diagnostic Test: Subjective Refraction, Diagnostic Test: BiomicroscopyPatients who had a Kowa lens implanted using the Yamane technique |
| Johnson | – | Device: IOL Master 700, Device: Casia-2, Device: MS-39, Device: OSIRIS, Device: Autorefractor, Diagnostic Test: Subjective Refraction, Diagnostic Test: BiomicroscopyPatients who had the ZA9003 (J\&J) lens implanted using the Yamane technique |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients who are undergoing (underwent)routine secondary cataract surgery will be included in this study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- best corrected visual acuity >0.1 (Snellen)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOL Master 700Biometry using the IOL Master 700 | Device | Johnson, Kowa Group |
| Casia-2Anterior segment-OCT to evaluate lens tilt | Device | Johnson, Kowa Group |
| MS-39Corneal Topography using the MS-39 | Device | Johnson, Kowa Group |
| OSIRISAbberometry using the OSIRIS-Abberometer | Device | Johnson, Kowa Group |
| AutorefractorEvaluation of Refraction using an Autorefractor | Device | Johnson, Kowa Group |
| Subjective RefractionRefraction performed by experienced staff | Diagnostic test | Johnson, Kowa Group |
| BiomicroscopySlit Lamp Examination | Diagnostic test | Johnson, Kowa Group |
Primary outcome
Tilt
Time frame: 6 Weeks
Postoperative Tilt
Autorefraction
Time frame: 6 Weeks
Refraction using an automated refractor
Subjective Refraction
Time frame: 6 Weeks
Refraction performed by experienced staff
Best corrected visual acuity
Time frame: 6 Weeks
Measurement performed by experienced staff
uncorrected visual acuity
Time frame: 6 Weeks
Measurement performed by experienced staff
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Bolz, MD study chair
JKU Linz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Cataract Surgery and Aphakia, run by Johannes Kepler University of Linz at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Silber, MSc (+43 5 7680 83 ext. 1944, christina.silber@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilt (time frame: 6 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.