NCT06102109

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. The main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.

Conditions

• Lens Luxation
• IOL Subluxation
• IOL Opacification
• Aphakia - No Lens Capsule

Interventions

Type	Name	Description
PROCEDURE	Pars plana vitrectomy	25gauge pars plana vitrectomy: to remove the vitreous if present
PROCEDURE	IOL explantation	Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2023-09-19
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-10-26
• Last updated: 2023-10-26

Locations

1 site across 1 country: Austria