Clinical trial NCT05779306: Performance of Two Sclera Fixated Intraocular Lens Concepts
Official title: Performance of Two Sclera Fixated Intraocular Lens Concepts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Complicated
Cataract Complications Operations
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited all underwent ocular surgery with implantation of a scleral fixated lens, either using the Carlevale lens or the Yamane technique

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.

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

Primary outcomes:
measure: Tilt
timeFrame: 6 Weeks
measure: Autorefraction
timeFrame: 6 Weeks
measure: Subjective Refraction
timeFrame: 6 Weeks
measure: Best corrected visual acuity
timeFrame: 6 Weeks
measure: uncorrected visual acuity
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
state: Oberösterreich
Study officials:
affiliation: Johannes Kepler University
name: Nino Hirnschall, MD
role: PRINCIPAL_INVESTIGATOR
References: