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YAMPOINT: 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 (Other)
Overall Status
Recruiting
CT.gov ID
NCT06102109
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
59.4
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pars plana vitrectomy
  • Procedure: IOL explantation
  • Procedure: Scleral IOL fixation Yamane Technique
  • Procedure: Scleral IOL fixation "4-flanged" Technique
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
Actual Study Start Date :
Sep 19, 2023
Anticipated Primary Completion Date :
Sep 1, 2028
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Yamane Arm

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

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

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

Procedure: Scleral 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.
Active Comparator: "4-flanged" Arm

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

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

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

Procedure: Scleral 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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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 Outcome Measures

  1. Best corrected visual outcome [12 weeks]

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

  2. Flange erosion and intrusion [3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Claudette Abela-Formanek, Univ. Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT06102109
Other Study ID Numbers:
  • Y4P0923
First Posted:
Oct 26, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Claudette Abela-Formanek, Univ. Prof. Dr., Medical University of Vienna
Scleral fixated IOL
Yamane
4 flanged technique
Additional relevant MeSH terms:
Aphakia

Study Results

No Results Posted as of Oct 26, 2023