RecruitingNot ApplicableNCT06102109

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


Sponsor

Medical University of Vienna

Enrollment

100 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • \- Necessity for IOL (re)fixation in the absence of capsular support
  • willing to give informed consent and follow-up the duration of study

Exclusion Criteria2

  • Anatomical or other contraindications for suture less IOL fixation, such as presence of a trabeculectomy bleb or scleromalacia
  • active inflammatory diseases of the eye

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Interventions

PROCEDUREPars plana vitrectomy

25gauge pars plana vitrectomy: to remove the vitreous if present

PROCEDUREIOL explantation

Removing if present a subluxated IOL from the anterior chamber or the vitreous cavity

PROCEDUREScleral 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.

PROCEDUREScleral 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.


Locations(1)

Medical University of Vienna

Vienna, Austria

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NCT06102109