Clinical trial NCT05912829: Comparison of Two Different Intraocular Lenses Implanted With Yamane Technique
Official title: Evaluation of Two Different Intraocular Lens Models After Lens Implantation Using the Yamane Technique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Secondary Cataract Surgery
Aphakia
Complicated Cataract Surgery
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients who are undergoing (underwent)routine secondary cataract surgery will be included in this study.

Brief summary: In case of instability or rupture of capsular bag occurs during cataract surgery, Yamane technique is one of the options to fix intracocularlens' haptics. Yamane technique uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel.

Aberrations, IOL tilting or even dislocations might occur and influence the final outcome of IOL implantation.

The aim of this study is the evaluation of the postoperative tilt of Kowa PU6AS using Yamane technique. Furthermore of the corrected and uncorrected visual acuity and the anterior chamber depth are being developed.

Detailed description: During uncomplicated cataract surgery, an intraocular lens (IOL) is implanted into the patient's capsular bag. If increased instability or rupture of this capsular bag occurs due to aggravated intraoperative conditions or IOL dislocation, several options are available to the surgeon to correct the aphakia, all characterized by their respective advantages and disadvantages, but with no clear superiority of any one method.

The popular Yamane technique, or "flanged IOL fixation", uses a double-needle technique that seamlessly fixes the haptics intrascleral by creating a scleral tunnel using two 30-gauge needles.

Examples of lenses used for this purpose are the TECNIS ZA9003 (Johnson\&Johnson, USA) and the Kowa PU6AS (Kowa, Japan). Another approach is the Carlevale FIL-SSF IOL (Soleko, Italy), which was developed specifically for use in aphakia with lack of capsular stability.

All types of implantation are not immune to aberrations, tilting or even dislocation. Many factors influence the final outcome of IOL implantation, be it 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 assurance, an evaluation of monthly and six-monthly data will now be performed. The aim of this study is the evaluation of the postoperative tilt of the Kowa PU6AS in Yamane technique, as well as the evaluation of the corrected and uncorrected visual acuity and the anterior chamber depth within the clinical quality management.

Eligibility criteria: Inclusion Criteria:

* Minimum age: 21 Years
* planned or performed lens implantation using the Kowa PU6AS or the Johnson \& Johnson ZA9003 using the Yamane technique
* signed patient consent form

Exclusion Criteria:

* best corrected visual acuity \>0.1 (Snellen)
* pregnancy

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
state: Upper Austria
city: Linz
country: Austria
facility: Department for Ophthalmology and Optometry
state: Upper Austria
Study officials:
affiliation: JKU Linz
name: Matthias Bolz, MD
role: STUDY_CHAIR
References: