Age Related CataractsNCT06053554
Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome
A study testing Phakoemulsification, Ziemer Z8 Femtolaser and Kowa Avansee Preset in people with Age Related Cataracts and Pseudoexfoliation Syndrome, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to compare the surgical outcomes of the two IOL implantation methods for eyes with cataract and PEX in a single-center and with highly experienced surgeons. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Age Related Cataracts, Pseudoexfoliation Syndrome
- What is being tested?
- Phakoemulsification, Ziemer Z8 Femtolaser and Kowa Avansee Preset
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 18 Sep 2023to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 - 100
- Necessity for bilateral cataract surgery with pseudoexfoliation syndrome
- willing to give informed consent and follow-up the duration of study
Who cannot join
- Endstage glaucoma
- Christalline lens sub/ luxation
- active inflammatory diseases of the eye
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Claudette ABELA-FORMANEK, Prof.Dr. contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Markus Schranz, Md
About this study
Official title: Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome: Lens in the Bag-technique Versus Lens in the Ciliary Sulcus With Optic Capture Technique
The aim of this study is to compare the surgical outcomes of the two IOL implantation methods for eyes with cataract and PEX in a single-center and with highly experienced surgeons. The goal is to acquire relevant information regarding these two IOL implantation techniques, which will help surgeons to decide which approach to choose, ultimately resulting in a benefit for patients with PEX syndrome who require cataract surgery.
The main questions are:
Is there a difference in lens tilt and decentration between the both methods. Is there a difference in the frequency and amount of capsular phimosis between the both methods.
Read the detailed description
This is a prospective, intraindividual comparative study of two routinely used surgical techniques for IOL implantation in extracapsular cataract surgery. On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. Until the point of IOL implantation the surgery is identical in both methods and the surgeon is blinded.
Femtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus to guarantee reproducible results in every eye. In case of an insufficient pupil size (smaller than 5.5mm), 2.4mm clear corneal incision and paracenteses are performed prior to laser docking and a pupil expansion device is implanted under anterior segment filling with viscoelastic to enlarge the pupil diameter. After the CCC and nucleus fragmentation the anterior segment is filled with viscoelastics, the rhexis lenticule is removed and hydrodisection of the nucleus is performed. Subsequently phacoemulsification for nucleus and irrigation/aspiration of the lens cortex is performed. The capsular bag and AC is then filled with a cohesive viscoelastic and the IOL is implanted as described above with the haptics in the back or with the haptics in the sulcus. At the end of surgery, the viscoelastic is removed using the irrigation aspiration probe, intracameral antibiotic is instilled, the CCI and paracenteses are hydrated and sealed.
Study investigators are blinded, however the selected method can be visible during the routinely performed slit-lamp examinations. During all evaluation and measuring processes (Evaluation of decentration, tilt, capsular phimoses, surgery time) the investigators are blinded. This study is performed by highly experienced surgeons, who have already performed both methods on a routine basis.
- Conditions
- Age Related Cataracts, Pseudoexfoliation Syndrome
- Being tested
- Phakoemulsification, Ziemer Z8 Femtolaser, Kowa Avansee Preset
- Keywords
- Femtolaser, Sulcus-IOL, Anterior segment, Lens tilt and decentration, Capsular phimoses
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhakoemulsificationProcedure or surgery
Femtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus toguarantee reproducible results in every eye.After the CCC and nucleus fragmentation the anterior segment is filled with viscoelastics, the rhexis lenticule is removed and hydrodisection of the nucleus is performed. Subsequently phacoemulsification for nucleus and irrigation/aspiration of the lens cortex is performed. The capsular bag and AC is then filled with a cohesive viscoelastic and the IOL is implanted with the haptics in the back or with the haptics in the sulcus. At the end of surgery, the viscoelastic is removed using the irrigation aspiration probe, intracameral antibiotic is instilled, the CCI and paracenteses are hydrated and sealed.
Ziemer Z8 FemtolaserDevice
The femto second laser used for certain steps (capsulorhexis, nucleus fragmentation) of the cataract surgery.
Kowa Avansee PresetDevice
The used 3 piece intra ocular lens
| Study group | Role | What they receive |
|---|---|---|
| Sulcus | Other | On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. Receives: Procedure: Phakoemulsification; Device: Ziemer Z8 Femtolaser; Device: Kowa Avansee Preset |
| In the bag | Other | On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. Receives: Procedure: Phakoemulsification; Device: Ziemer Z8 Femtolaser; Device: Kowa Avansee Preset |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of lens tilt and decentration from baseline to month 60 postoperatively
The change of lens tilt and decentration from baseline to month 60 postoperatively, measured by anterior segment optical coherence tomography.
Measured: Baseline to month 60 postoperatively
The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method.
The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method at month 60 post operatively, measured by anterior segment optical coherence tomography.
Measured: Month 60 postoperatively
Secondary outcomes (1)
Capsular phimoses
The amount of anterior capsular phimosis and rhexis shrinking, evaluated on anterior segment images.
Measured: Month 60 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start18 Sep 2023
- Primary completionMay 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudette Abela-Formanek, Medical University of Vienna
- Investigators
- Claudette ABELA-FORMANEK, Prof. Dr., Principal investigator, Department for Ophthalmology and Optometry, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053554
- Sponsor's protocol ID
- PEX-2305
- Status last verified
- Oct 2023
- First submitted
- 11 May 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publications in peer reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Two Surgical Methods for IOLImplantation in Eyes With Pseudoexfoliation Syndrome: Lens in the Bag-technique Versus Lens in the Ciliary Sulcus With Optic Capture Technique
- ClinicalTrials.gov ID
- NCT06053554
- Acronym / sponsor ID
- PEX-2305
- Conditions
- Age Related Cataracts, Pseudoexfoliation Syndrome
- Keywords
- Femtolaser, Sulcus-IOL, Anterior segment, Lens tilt and decentration, Capsular phimoses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 25 Sep 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 aim of this study is to compare the surgical outcomes of the two IOL implantation methods for eyes with cataract and PEX in a single-center and with highly experienced surgeons. The goal is to acquire relevant information regarding these two IOL implantation techniques, which will help surgeons to decide which approach to choose, ultimately resulting in a benefit for patients with PEX syndrome who require cataract surgery.
The main questions are:
Is there a difference in lens tilt and decentration between the both methods. Is there a difference in the frequency and amount of capsular phimosis between the both methods.
Detailed description
This is a prospective, intraindividual comparative study of two routinely used surgical techniques for IOL implantation in extracapsular cataract surgery. On the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. Until the point of IOL implantation the surgery is identical in both methods and the surgeon is blinded.
Femtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus to guarantee reproducible results in every eye. In case of an insufficient pupil size (smaller than 5.5mm), 2.4mm clear corneal incision and paracenteses are performed prior to laser docking and a pupil expansion device is implanted under anterior segment filling with viscoelastic to enlarge the pupil diameter. After the CCC and nucleus fragmentation the anterior segment is filled with viscoelastics, the rhexis lenticule is removed and hydrodisection of the nucleus is performed. Subsequently phacoemulsification for nucleus and irrigation/aspiration of the lens cortex is performed. The capsular bag and AC is then filled with a cohesive viscoelastic and the IOL is implanted as described above with the haptics in the back or with the haptics in the sulcus. At the end of surgery, the viscoelastic is removed using the irrigation aspiration probe, intracameral antibiotic is instilled, the CCI and paracenteses are hydrated and sealed.
Study investigators are blinded, however the selected method can be visible during the routinely performed slit-lamp examinations. During all evaluation and measuring processes (Evaluation of decentration, tilt, capsular phimoses, surgery time) the investigators are blinded. This study is performed by highly experienced surgeons, who have already performed both methods on a routine basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulcus | Other | Procedure: Phakoemulsification, Device: Ziemer Z8 Femtolaser, Device: Kowa Avansee PresetOn the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. |
| In the bag | Other | Procedure: Phakoemulsification, Device: Ziemer Z8 Femtolaser, Device: Kowa Avansee PresetOn the day baseline examination, the first eye to be operated is randomised to receive a 3p-IOL implantation in the capsular bag (group 1) or a 3p-IOL haptics in the ciliary sulcus with the IOL optic tucked in the capsular bag (group 2). The second eye to be operated receives the other method. The eye with the lower visual acuity is operated first, in case of identical visual acuity values the for the patient subjective worse eye is operated first. This procedure is clinical standard. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 60 - 100
- Necessity for bilateral cataract surgery with pseudoexfoliation syndrome
- willing to give informed consent and follow-up the duration of study
Key exclusion criteria (3 listed)
- Endstage glaucoma
- Christalline lens sub/ luxation
- active inflammatory diseases of the eye
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 |
|---|---|---|
| PhakoemulsificationFemtolaser is used to perform a standard 5.0mm CCC centred on the pupil or limbus and to fragment the lens nucleus toguarantee reproducible results in every eye.After the CCC and nucleus fragmentation the anterior segment is filled with viscoelastics, the rhexis lenticule is removed and hydrodisection of the nucleus is performed. Subsequently phacoemulsification for nucleus and irrigation/aspiration of the lens cortex is performed. The capsular bag and AC is then filled with a cohesive viscoelastic and the IOL is implanted with the haptics in the back or with the haptics in the sulcus. At the end of surgery, the viscoelastic is removed using the irrigation aspiration probe, intracameral antibiotic is instilled, the CCI and paracenteses are hydrated and sealed. | Procedure or surgery | In the bag, Sulcus |
| Ziemer Z8 FemtolaserThe femto second laser used for certain steps (capsulorhexis, nucleus fragmentation) of the cataract surgery. | Device | In the bag, Sulcus |
| Kowa Avansee PresetThe used 3 piece intra ocular lens | Device | In the bag, Sulcus |
Primary outcome
The change of lens tilt and decentration from baseline to month 60 postoperatively
Time frame: Baseline to month 60 postoperatively
The change of lens tilt and decentration from baseline to month 60 postoperatively, measured by anterior segment optical coherence tomography.
The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method.
Time frame: Month 60 postoperatively
The difference in decentration and tilt between the "in the bag" and the sulcus intra ocular lens implantation method at month 60 post operatively, measured by anterior segment optical coherence tomography.
1 secondary outcome
Capsular phimoses
Time frame: Month 60 postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. Publications in peer reviewed journals
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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.
Claudette ABELA-FORMANEK, Prof.Dr. contact
Claudette ABELA-FORMANEK, Prof. Dr. principal investigator
Department for Ophthalmology and Optometry, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phakoemulsification, Ziemer Z8 Femtolaser and Kowa Avansee Preset in people with Age Related Cataracts and Pseudoexfoliation Syndrome, run by Medical University of Vienna 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudette ABELA-FORMANEK, Prof.Dr. (+43(0)14040079680, claudette.abela-formanek@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of lens tilt and decentration from baseline to month 60 postoperatively (time frame: Baseline to month 60 postoperatively). The study lists 2 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 24 Oct 2023.