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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yamane Arm | Active Comparator | Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera. |
|
| "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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | 25gauge pars plana vitrectomy: to remove the vitreous if present |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Markus Schranz, Md | Contact | +4314040079690 | markus.schranz@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| IOL explantation | Procedure | Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity |
|
| Scleral IOL fixation Yamane Technique | Procedure | 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 | Procedure | 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. |
|
| 3 years |
| ID | Term |
|---|---|
| D007906 | Lens Subluxation |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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