Ophthalmological DisorderNCT06069752
Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery
An observational study of Ophthalmological Disorder, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability. In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Ophthalmological Disorder
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 8 Mar 2022to 31 Mar 2024
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 50 subjects requiring IOL implantation to treat aphakia after extracapsular cataract extraction or phacoemulsification.
Who may be able to join
- Adult subject with a minimum age of 22 years
- Planned natural lens replacement with posterior chamber IOL implantation
- Clear intraocular media other than cataract
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
- Ability to consent to the participation in study
- Signed informed consent
Who cannot join
- Corneal pathology/ectasia
- Prior ophthalmic surgery
- Zonular-defects, unstable bag
- Macular pathologies
- Expected Visual acuity of less than 0.63 (decimal)
- Glaucoma
Show all 9Show fewer
- Use of systemic or ocular medication that might affect vision
- Patient is pregnant, plans to become pregnant, is lactating
- Concurrent participation in any other clinical trial with an investigation product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery
The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
Read the detailed description
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.
Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.
- Conditions
- Ophthalmological Disorder
- Medical subject headings
- Eye Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilt and decentration of intraocular lens measured in degrees
Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery
Measured: 1 month post surgery compared with 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start8 Mar 2022
- Primary completion22 Nov 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ophthalmological DisorderStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Responsible party
- Principal investigator, Matthias Bolz, Johannes Kepler University of Linz
- Investigators
- Matthias Bolz, MD, Principal investigator, JKU Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069752
- Sponsor's protocol ID
- KUK-Ophthalmology-003
- Status last verified
- May 2025
- First submitted
- 8 Aug 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Casazza M, Reifeltshammer SA, Hirnschall N, Mariacher S, Laubichler P, Siska R, Wendelstein J, Bolz M. Randomized controlled bilateral comparison of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. BMJ Surg Interv Health Technol. 2025 Jul 10;7(1):e000342. doi: 10.1136/bmjsit-2024-000342. eCollection 2025.
PubMed 40662090
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT06069752
- Acronym / sponsor ID
- KUK-Ophthalmology-003
- Conditions
- Ophthalmological Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Carl Zeiss Meditec, Inc.
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Oct 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.
The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
Detailed description
In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.
Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.
Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 50 subjects requiring IOL implantation to treat aphakia after extracapsular cataract extraction or phacoemulsification.
Key inclusion criteria (6 listed)
- Adult subject with a minimum age of 22 years
- Planned natural lens replacement with posterior chamber IOL implantation
- Clear intraocular media other than cataract
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
- Ability to consent to the participation in study
Key exclusion criteria (9 listed)
- Corneal pathology/ectasia
- Prior ophthalmic surgery
- Zonular-defects, unstable bag
- Macular pathologies
- Expected Visual acuity of less than 0.63 (decimal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tilt and decentration of intraocular lens measured in degrees
Time frame: 1 month post surgery compared with 12 months post surgery
Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 40662090Casazza M, Reifeltshammer SA, Hirnschall N, Mariacher S, Laubichler P, Siska R, Wendelstein J, Bolz M. Randomized controlled bilateral comparison of femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. BMJ Surg Interv Health Technol. 2025 Jul 10;7(1):e000342. doi: 10.1136/bmjsit-2024-000342. eCollection 2025.
- 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 principal investigator
JKU Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmological Disorder, run by Johannes Kepler University of Linz at 1 site 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilt and decentration of intraocular lens measured in degrees (time frame: 1 month post surgery compared with 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069752, which also lists 1 linked publication.
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 16 May 2025.