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

Not Applicable

Recruiting

• Conditions: IOL Opacification; Aphakia - No Lens Capsule; Lens Luxation; IOL Subluxation
• Interventions: Procedure: Pars plana vitrectomy; Procedure: IOL explantation; Procedure: Scleral IOL fixation Yamane Technique; Procedure: Scleral IOL fixation "4-flanged" Technique

• Registration Number: NCT06102109
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-19
• Study First Submitted: 2023-09-22
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-20
• Last Update Submitted: 2023-10-20
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"4-flanged" Arm	Pars plana vitrectomy	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
Yamane Arm	IOL explantation	Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.
Yamane Arm	Pars plana vitrectomy	Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.
"4-flanged" Arm	IOL explantation	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
Yamane Arm	Scleral IOL fixation Yamane Technique	Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.
"4-flanged" Arm	Scleral IOL fixation "4-flanged" Technique	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

Primary Outcome Measures

Name	Time	Method
IOL tilt	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	3 years	The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria