Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
NCT ID: NCT06102109
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-19
2028-09-30
Brief Summary
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The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Yamane Arm
Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.
Pars plana vitrectomy
25gauge pars plana vitrectomy: to remove the vitreous if present
IOL explantation
Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity
Scleral IOL fixation Yamane Technique
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.
"4-flanged" Arm
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
Pars plana vitrectomy
25gauge pars plana vitrectomy: to remove the vitreous if present
IOL explantation
Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity
Scleral IOL fixation "4-flanged" Technique
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.
Interventions
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Pars plana vitrectomy
25gauge pars plana vitrectomy: to remove the vitreous if present
IOL explantation
Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity
Scleral IOL fixation Yamane Technique
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" Technique
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.
Eligibility Criteria
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Inclusion Criteria
* willing to give informed consent and follow-up the duration of study
Exclusion Criteria
* active inflammatory diseases of the eye
18 Years
100 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Claudette Abela-Formanek
Univ. Prof. Dr.
Locations
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Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Markus Schranz, Md
Role: primary
Other Identifiers
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Y4P0923
Identifier Type: -
Identifier Source: org_study_id
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