Lens LuxationYAMPOINTNCT06102109
Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
A study testing Pars plana vitrectomy, IOL explantation and Scleral IOL fixation Yamane Technique in people with Lens Luxation and IOL Subluxation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lens Luxation, IOL Subluxation, IOL Opacification
- What is being tested?
- Pars plana vitrectomy, IOL explantation and Scleral IOL fixation Yamane Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 19 Sep 2023to Sep 2028
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Necessity for IOL (re)fixation in the absence of capsular support
- willing to give informed consent and follow-up the duration of study
Who cannot join
- Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
- 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.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Markus Schranz, Md
About this study
This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique.
The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.
- Being tested
- Pars plana vitrectomy, IOL explantation, Scleral IOL fixation Yamane Technique, Scleral IOL fixation "4-flanged" Technique
- Keywords
- Scleral fixated IOL, Yamane, 4 flanged technique
- Medical subject headings
- Lens Subluxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pars plana vitrectomyProcedure or surgery
25gauge pars plana vitrectomy: to remove the vitreous if present
IOL explantationProcedure or surgery
Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity
Scleral IOL fixation Yamane TechniqueProcedure or surgery
Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera using only its haptics, which are externalised 2.5mm behind the blue line. The haptic ends are flanged using a thermo cautery to prevent slipping back in.
Scleral IOL fixation "4-flanged" TechniqueProcedure or surgery
Scleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physical Micropure 123) gets fixated in the sclera using one 6.0 polypropylene suture per 2 haptic loops, which are put trough the loops in a W shape. The suture ends are externalised 2.5mm behind the blue line and its ends are flanged using a thermo cautery to prevent slipping back in.
| Study group | Role | What they receive |
|---|---|---|
| Yamane Arm | Active comparator | Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera. Receives: Procedure: Pars plana vitrectomy; Procedure: IOL explantation; Procedure: Scleral IOL fixation Yamane Technique |
| "4-flanged" Arm | Active comparator | Scleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physiol Micropure 123) gets fixated in the sclera using 6.0 polypropylene suture Receives: Procedure: Pars plana vitrectomy; Procedure: IOL explantation; Procedure: Scleral IOL fixation "4-flanged" Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL tilt
The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
Measured: 3 years
IOL decentration
The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
Measured: 3 years
Secondary outcomes (2)
Best corrected visual outcome
The achieved best corrected visual (in Snellen) outcome after Intraocular lens implantation
Measured: 12 weeks
Flange erosion and intrusion
Risks of flange erosion trough the conjuctiva or intrusion through the sclera over the investigated time period
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start19 Sep 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens LuxationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102109
- Sponsor's protocol ID
- Y4P0923
- Acronym
- YAMPOINT
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
- ClinicalTrials.gov ID
- NCT06102109
- Acronym / sponsor ID
- YAMPOINT / Y4P0923
- Keywords
- Scleral fixated IOL, Yamane, 4 flanged technique
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 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.
This study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral IOL fixation techniques: Yamane technique versus the 4-flanged technique.
The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yamane Arm | Active comparator | Procedure: Pars plana vitrectomy, Procedure: IOL explantation, Procedure: Scleral IOL fixation Yamane TechniqueScleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera. |
| "4-flanged" Arm | Active comparator | Procedure: Pars plana vitrectomy, Procedure: IOL explantation, Procedure: Scleral IOL fixation "4-flanged" TechniqueScleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physiol Micropure 123) gets fixated in the sclera using 6.0 polypropylene suture |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Necessity for IOL (re)fixation in the absence of capsular support
- willing to give informed consent and follow-up the duration of study
Key exclusion criteria (2 listed)
- Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
- 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 |
|---|---|---|
| Pars plana vitrectomy25gauge pars plana vitrectomy: to remove the vitreous if present | Procedure or surgery | "4-flanged" Arm, Yamane Arm |
| IOL explantationRemoving if present a subluxated IOL from the anterior chamber or the vitreous cavity | Procedure or surgery | "4-flanged" Arm, Yamane Arm |
| Scleral IOL fixation Yamane TechniqueScleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera using only its haptics, which are externalised 2.5mm behind the blue line. The haptic ends are flanged using a thermo cautery to prevent slipping back in. | Procedure or surgery | Yamane Arm |
| Scleral IOL fixation "4-flanged" TechniqueScleral IOL fixation using the 4 flanged technique. A 4 loop haptic IOL (Physical Micropure 123) gets fixated in the sclera using one 6.0 polypropylene suture per 2 haptic loops, which are put trough the loops in a W shape. The suture ends are externalised 2.5mm behind the blue line and its ends are flanged using a thermo cautery to prevent slipping back in. | Procedure or surgery | "4-flanged" Arm |
Primary outcome
IOL tilt
Time frame: 3 years
The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
IOL decentration
Time frame: 3 years
The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)
2 secondary outcomes
Best corrected visual outcome
Time frame: 12 weeks
Flange erosion and intrusion
Time frame: 3 years
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 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pars plana vitrectomy, IOL explantation and Scleral IOL fixation Yamane Technique in people with Lens Luxation and IOL Subluxation, 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 2 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: looking for participants now, as of the sponsor's last update on 26 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 Markus Schranz, Md (+4314040079690, markus.schranz@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL tilt (time frame: 3 years). 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 26 Oct 2023.