Comparing two surgical methods for fixing intraocular lenses without capsular support
Long-term Results of Two Surgical Methods for Scleral IOL Implantation and Fixation in Eyes Without Capsular Support: Yamane- Versus 4-flanged Technique
NA · Medical University of Vienna · NCT06102109
This study is testing two different surgical methods to see which one works better for fixing eye lenses in patients who don't have the usual support from the eye's capsule.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06102109 on ClinicalTrials.gov |
What this trial studies
This study compares the long-term outcomes of two surgical techniques for scleral fixation of intraocular lenses (IOL) in patients lacking capsular support. The techniques being evaluated are the Yamane technique and the 4-flanged technique, focusing on postoperative lens tilt, surgery duration, complication rates, and scleral integrity. Participants will undergo pars plana vitrectomy and IOL fixation using one of the two methods, with follow-up assessments to determine effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are patients requiring IOL fixation due to lens luxation or subluxation without capsular support.
Not a fit: Patients with anatomical contraindications for sutureless IOL fixation or active inflammatory eye diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective surgical technique for IOL fixation, improving patient outcomes and reducing complications.
How similar studies have performed: While there have been studies on scleral fixation techniques, this specific comparison of the Yamane and 4-flanged techniques is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Study coordinator: Markus Schranz, Md
- Email: markus.schranz@meduniwien.ac.at
- Phone: +4314040079690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lens Luxation, IOL Subluxation, IOL Opacification, Aphakia - No Lens Capsule, Scleral fixated IOL, Yamane, 4 flanged technique