Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique

Conditions
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Lens Luxation, IOL Subluxation, IOL Opacification, Aphakia - No Lens Capsule

Intervention / Treatment
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* Procedure: Pars plana vitrectomy
* Procedure: IOL explantation
* Procedure: Scleral IOL fixation Yamane Technique
* Procedure: Scleral IOL fixation 4-flanged Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Necessity for IOL (re)fixation in the absence of capsular support willing to give informed consent and follow-up the duration of study Exclusion Criteria: Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia active inflammatory diseases of the eye

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Yamane Arm<br>Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera. | Procedure: Pars plana vitrectomy<br>* 25gauge pars plana vitrectomy: to remove the vitreous if present<br>Procedure: IOL explantation<br>* Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity<br>Procedure: Scleral IOL fixation Yamane Technique<br>* 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.<br>|
| Active Comparator: 4-flanged Arm<br>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 | Procedure: Pars plana vitrectomy<br>* 25gauge pars plana vitrectomy: to remove the vitreous if present<br>Procedure: IOL explantation<br>* Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity<br>Procedure: Scleral IOL fixation 4-flanged Technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL tilt | The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan) | 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) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual outcome | The achieved best corrected visual (in Snellen) outcome after Intraocular lens implantation | 12 weeks | 
| Flange erosion and intrusion | Risks of flange erosion trough the conjuctiva or intrusion through the sclera over the investigated time period | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleral fixated IOL, Yamane, 4 flanged technique