Carlevale: Performance of Two Sclera Fixated Intraocular Lens Concepts
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Carlevale Patients who had a Carlevale lens implanted |
Device: IOL Master 700
Biometry using the IOL Master 700
Device: Casia-2
Anterior segment-OCT to evaluate lens tilt
Device: MS-39
Corneal Topography using the MS-39
Device: OSIRIS
Abberometry using the OSIRIS-Abberometer
Device: Autorefractor
Evaluation of Refraction using an Autorefractor
Diagnostic Test: Subjective Refraction
Refraction performed by experienced staff
|
| Yamane Patients who had a lens implanted using Yamane technique |
Device: IOL Master 700
Biometry using the IOL Master 700
Device: Casia-2
Anterior segment-OCT to evaluate lens tilt
Device: MS-39
Corneal Topography using the MS-39
Device: OSIRIS
Abberometry using the OSIRIS-Abberometer
Device: Autorefractor
Evaluation of Refraction using an Autorefractor
Diagnostic Test: Subjective Refraction
Refraction performed by experienced staff
|
Outcome Measures
Primary Outcome Measures
- Tilt [6 Weeks]
Postoperative Tilt
- Autorefraction [6 Weeks]
Refraction using an automated refractor
- Subjective Refraction [6 Weeks]
Refraction performed by experienced staff
- Best corrected visual acuity [6 Weeks]
Measurement performed by experienced staff
- uncorrected visual acuity [6 Weeks]
Measurement performed by experienced staff
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria | Linz | Oberösterreich | Austria | 4020 |
Sponsors and Collaborators
- Johannes Kepler University of Linz
Investigators
- Principal Investigator: Nino Hirnschall, MD, Johannes Kepler University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KUK-Ophthalmology-011