NCT05779306

Performance of Two Sclera Fixated Intraocular Lens Concepts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Johannes Kepler University of Linz · Academic / Other
• Sex: All
• Age: 21 Years – 110 Years
• Healthy volunteers: —

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.

Conditions

• Cataract Complicated
• Cataract Complications Operations

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-19
• Primary completion: 2024-01-01
• Completion: 2024-01-30
• First posted: 2023-03-22
• Last updated: 2024-03-08

Locations

1 site across 1 country: Austria

Regulatory

• FDA-regulated device study