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Clinical Trials/NCT06102109
NCT06102109
Recruiting
Not Applicable

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 Vienna1 site in 1 country100 target enrollmentSeptember 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lens Luxation
Sponsor
Medical University of Vienna
Enrollment
100
Locations
1
Primary Endpoint
IOL tilt
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2023
End Date
September 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudette Abela-Formanek

Univ. Prof. Dr.

Medical University of Vienna

Eligibility Criteria

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

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)

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

  • Best corrected visual outcome(12 weeks)
  • Flange erosion and intrusion(3 years)

Study Sites (1)

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