Aphakia - No Lens Capsule, IOL Opacification, IOL Subluxation, Lens Luxation
Conditions
Keywords
Scleral fixated IOL, Yamane, 4 flanged technique
Brief 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.
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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOL tilt | 3 years | The postoperative intra ocular lens tilt in degree measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan) |
| IOL decentration | 3 years | The postoperative intra ocular lens decentration in millimetres measured by an anterior segment optical coherence tomography device (Casia 2, Tommy, Japan) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual outcome | 12 weeks | The achieved best corrected visual (in Snellen) outcome after Intraocular lens implantation |
| Flange erosion and intrusion | 3 years | Risks of flange erosion trough the conjuctiva or intrusion through the sclera over the investigated time period |
Countries
Austria
Contacts
Primary ContactMarkus Schranz, Md
Outcome results
None listed