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Recruiting NCT06102109

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

No phase Interventional Lens Luxation IOL Subluxation IOL Opacification Aphakia - No Lens Capsule

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pars plana vitrectomy, IOL explantation, Scleral IOL fixation Yamane Technique, Scleral IOL fixation "4-flanged" Technique.
Who it may be relevant to
Registry conditions: Lens Luxation, IOL Subluxation, IOL Opacification, Aphakia - No Lens Capsule. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • IOL tilt [Time frame: 3 years]
  • IOL decentration [Time frame: 3 years]
Secondary outcome measures (2)
  • Best corrected visual outcome [Time frame: 12 weeks]
  • Flange erosion and intrusion [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Identifiers

NCT: NCT06102109 · Y4P0923

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗