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Clinical Trials/NCT05779306
NCT05779306
Completed
Not Applicable

Performance of Two Sclera Fixated Intraocular Lens Concepts

Johannes Kepler University of Linz1 site in 1 country26 target enrollmentJanuary 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract Complicated
Sponsor
Johannes Kepler University of Linz
Enrollment
26
Locations
1
Primary Endpoint
Best corrected visual acuity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

To evaluate and compare the post-operative outcome of two different sceral fixated IOL concepts, the Yamane method (ZA9003, J&J, USA) and the Carlevale IOL (FIL-SSF, Soleko, Italy).

Detailed Description

Various approaches to fix the haptics in the sclera can be found in literature. A distinction can be made between suture-fixed and sutureless techniques. The former often proves to be technically challenging and complicated, which has led to an increased rethinking towards sutureless implantation in recent years. The popular Yamane technique or "flanged IOL fixation" uses a double-needle technique that creates a scleral tunnel and fixates the haptics seamlessly using two 30-gauge needles. However, the haptics must be bent for this purpose Thus, this method is not ideal, since besides from the high degree of manipulation necessary for implantation of the IOL, it is also prone to dislocation and tilt. A more recent approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with a lack of capsular stability. Using two t-shaped anchors, the lens is positioned in two scleral flaps at 180 degrees to each other, without the preparation of a tunnel or excessive manipulation of the haptics. These two self-blocking anchors also provide a great deal of stability. The extent of abberations is also much less with this type of lens implantation, as the fixed position reduces the risk of them. Thus, the Carlevale technique represents a new, potentially superior option for intrascleral fixation. However, all these types of implantation are not free from aberrations, tilt, or even dislocation. Many factors influence the outcome of IOL implantation, the optimal choice of intraocular lens power, the surgeon's experience regarding fixation in more challenging eyes, or individual anatomical conditions. As part of quality management, an evaluation of monthly and six-monthly data will be performed. The aim of this study is the evaluation of the postoperative tilt of the Carlevale lens, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management. Patients who have already undergone surgery are called to our clinic by telephone at the earliest 6 weeks after surgery for a one-time follow-up appointment. The collected data is then evaluated and analyzed as well as compared to the Yamane data.

Registry
clinicaltrials.gov
Start Date
January 19, 2023
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Kepler University of Linz
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • minimum age of 21 years
  • planned surgery or already taken place surgery using a scleral fixated lens

Exclusion Criteria

  • best corrected visual acuity \<0.05 Snellen
  • pregnancy
  • missing informed consent form

Outcomes

Primary Outcomes

Best corrected visual acuity

Time Frame: 6 Weeks

Measurement performed by experienced staff

uncorrected visual acuity

Time Frame: 6 Weeks

Measurement performed by experienced staff

Tilt

Time Frame: 6 Weeks

Postoperative Tilt

Autorefraction

Time Frame: 6 Weeks

Refraction using an automated refractor

Subjective Refraction

Time Frame: 6 Weeks

Refraction performed by experienced staff

Study Sites (1)

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