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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Schranz, Md; Phone Number: +4314040079690; Email: markus.schranz@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Markus Schranz, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yamane Arm; Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.	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.
Active Comparator: "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	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 "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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Scleral fixated IOL; Yamane; 4 flanged technique
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: Y4P0923

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No