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

Medical University of Vienna

Status: Enrolling

Conditions: Lens Luxation; Aphakia - No Lens Capsule; IOL Subluxation; IOL Opacification

Treatments: Procedure: Scleral IOL fixation "4-flanged" Technique; Procedure: IOL explantation; Procedure: Pars plana vitrectomy; Procedure: Scleral IOL fixation Yamane Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06102109

Y4P0923

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Yamane Arm

Active Comparator group

Description:

Scleral IOL fixation using the Yamane technique. A 3 piece IOL (Kowa Avansee Preset) gets fixated in the sclera.

Treatment:

Procedure: Scleral IOL fixation Yamane Technique

Procedure: Pars plana vitrectomy

Procedure: IOL explantation

"4-flanged" Arm

Active Comparator group

Description:

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

Treatment:

Procedure: Pars plana vitrectomy

Procedure: Scleral IOL fixation "4-flanged" Technique

Procedure: IOL explantation