Cataract ComplicatedCarlevaleNCT05779306
Performance of Two Sclera Fixated Intraocular Lens Concepts
An observational study of Cataract Complicated and Cataract Complications Operations, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J\&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy). Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Cataract Complicated, Cataract Complications Operations
- What is being tested?
- IOL Master 700, Casia-2 and MS-39
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- 19 Jan 2023to 30 Jan 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 21 to 110 years
- All sexes
- Adult, Older adult
Study population: Patients recruited all underwent ocular surgery with implantation of a scleral fixated lens, either using the Carlevale lens or the Yamane technique
Who may be able to join
- minimum age of 21 years
- planned surgery or already taken place surgery using a scleral fixated lens
Who cannot join
- best corrected visual acuity <0.05 Snellen
- pregnancy
- missing informed consent form
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
Linz, Upper Austria, 4020
About this study
To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J\&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).
Read the detailed description
Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years.
The popular Yamane technique or "flanged IOL fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt.
A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation.
However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, 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 management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment.
The collected data is then evaluated and analyzed as well as compared to the Yamane data.
- Being tested
- IOL Master 700, Casia-2, MS-39, OSIRIS, Autorefractor
- Medical subject headings
- Capsule Opacification
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
| Study group | Role | What they receive |
|---|---|---|
| Carlevale | Patients who had a Carlevale lens implanted Receives: Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic Test: Subjective Refraction | |
| Yamane | Patients who had a lens implanted using Yamane technique Receives: Device: IOL Master 700; Device: Casia-2; Device: MS-39; Device: OSIRIS; Device: Autorefractor; Diagnostic Test: Subjective Refraction |
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 Mar 2023
- Study start19 Jan 2023
- Primary completion1 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract ComplicatedStudies 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
- Other
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nino Hirnschall, MD, Principal investigator, Johannes Kepler University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779306
- Sponsor's protocol ID
- KUK-Ophthalmology-011
- Acronym
- Carlevale
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Two Sclera Fixated Intraocular Lens Concepts
- ClinicalTrials.gov ID
- NCT05779306
- Acronym / sponsor ID
- Carlevale / KUK-Ophthalmology-011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 22 Mar 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.
To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J\&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).
Detailed description
Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years.
The popular Yamane technique or "flanged IOL fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt.
A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation.
However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, 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 management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment.
The collected data is then evaluated and analyzed as well as compared to the Yamane data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carlevale | – | Device: IOL Master 700, Device: Casia-2, Device: MS-39, Device: OSIRIS, Device: Autorefractor, Diagnostic Test: Subjective RefractionPatients who had a Carlevale lens implanted |
| Yamane | – | Device: IOL Master 700, Device: Casia-2, Device: MS-39, Device: OSIRIS, Device: Autorefractor, Diagnostic Test: Subjective RefractionPatients who had a lens implanted using Yamane technique |
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients recruited all underwent ocular surgery with implantation of a scleral fixated lens, either using the Carlevale lens or the Yamane technique
Key inclusion criteria (2 listed)
- minimum age of 21 years
- planned surgery or already taken place surgery using a scleral fixated lens
Key exclusion criteria (3 listed)
- best corrected visual acuity <0.05 Snellen
- pregnancy
- missing informed consent form
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 | Carlevale, Yamane |
| Casia-2Anterior segment-OCT to evaluate lens tilt | Device | Carlevale, Yamane |
| MS-39Corneal Topography using the MS-39 | Device | Carlevale, Yamane |
| OSIRISAbberometry using the OSIRIS-Abberometer | Device | Carlevale, Yamane |
| AutorefractorEvaluation of Refraction using an Autorefractor | Device | Carlevale, Yamane |
| Subjective RefractionRefraction performed by experienced staff | Diagnostic test | Carlevale, Yamane |
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
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 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cataract Complicated
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
Recruiting
Evaluation of Phacogoniotomy in Medically-controlled POAG
Glaucoma, Open-Angle, Cataract Complicated
RecruitingObservational study
The Cohort Study of Pediatric Cataract
Pediatric Cataract
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.
Nino Hirnschall, MD principal investigator
Johannes Kepler University
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 Cataract Complicated and Cataract Complications Operations, 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 2 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: finished, as of the sponsor's last update on 8 Mar 2024. 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 (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 8 Mar 2024.