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NCT Number: NCT06102109

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

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.

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Key information

Conditions

Lens Luxation Aphakia - No Lens Capsule Eye Diseases IOL Opacification IOL Subluxation Lens Diseases Lens Subluxation

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Markus Schranz, Md

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pars plana vitrectomy

Procedure

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

IOL explantation

Procedure

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

Scleral IOL fixation Yamane Technique

Procedure

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.

Scleral IOL fixation "4-flanged" Technique

Procedure

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 outcomes

  1. IOL tilt

    Time frame: 3 years

    The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)

  2. IOL decentration

    Time frame: 3 years

    The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan)

Secondary outcomes

  1. Best corrected visual outcome

    Time frame: 12 weeks

    The achieved best corrected visual (in Snellen) outcome after Intraocular lens implantation

  2. Flange erosion and intrusion

    Time frame: 3 years

    Risks of flange erosion trough the conjuctiva or intrusion through the sclera over the investigated time period

Study contacts

Contact information is provided by the study sponsor or research team.

Markus Schranz, Md

CONTACT

[email protected]

+4314040079690

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: YAMPOINT

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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