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

Medical University of Vienna100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Lens Luxation IOL Subluxation IOL Opacification Aphakia - No Lens Capsule

Interventions

Scleral IOL fixation Yamane TechniquePROCEDURE

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" TechniquePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

IOL tilt

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

Time frame: 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)

Time frame: 3 years

Secondary Outcomes

Best corrected visual outcome

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

Time frame: 12 weeks

Flange erosion and intrusion

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

Time frame: 3 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts