Performance of Two Sclera Fixated Intraocular Lens Concepts
- Conditions
- Cataract ComplicatedCataract Complications Operations
- Registration Number
- NCT05779306
- Lead Sponsor
- Johannes Kepler University of Linz
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- minimum age of 21 years
- planned surgery or already taken place surgery using a scleral fixated lens
- best corrected visual acuity <0.05 Snellen
- pregnancy
- missing informed consent form
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best corrected visual acuity 6 Weeks Measurement performed by experienced staff
uncorrected visual acuity 6 Weeks Measurement performed by experienced staff
Tilt 6 Weeks Postoperative Tilt
Autorefraction 6 Weeks Refraction using an automated refractor
Subjective Refraction 6 Weeks Refraction performed by experienced staff
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
🇦🇹Linz, Oberösterreich, Austria
Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria🇦🇹Linz, Oberösterreich, Austria