Skip to content

Performance of Two Sclera Fixated Intraocular Lens Concepts

Performance of Two Sclera Fixated Intraocular Lens Concepts

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05779306
Acronym
Carlevale
Enrollment
26
Registered
2023-03-22
Start date
2023-01-19
Completion date
2024-01-30
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Complicated, Cataract Complications Operations

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.

Interventions

Biometry using the IOL Master 700

DEVICECasia-2

Anterior segment-OCT to evaluate lens tilt

DEVICEMS-39

Corneal Topography using the MS-39

DEVICEOSIRIS

Abberometry using the OSIRIS-Abberometer

Evaluation of Refraction using an Autorefractor

DIAGNOSTIC_TESTSubjective Refraction

Refraction performed by experienced staff

Sponsors

Johannes Kepler University of Linz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
21 Years to 110 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Tilt6 WeeksPostoperative Tilt
Autorefraction6 WeeksRefraction using an automated refractor
Subjective Refraction6 WeeksRefraction performed by experienced staff
Best corrected visual acuity6 WeeksMeasurement performed by experienced staff
uncorrected visual acuity6 WeeksMeasurement performed by experienced staff

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026