Clinical trial NCT05462067: Combined EDOF / Trifocal
Official title: Visual Performance of Patients With Either Bilateral Implantation of the ZEISS AT LARA or the ZEISS AT LARA in One Eye and ZEISS AT LISA Tri in the Other (Presbyopia IOL Concept Evaluation).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain postoperative visual performance data of patients with bilateral implantation of the AT LARA IOL or the AT LARA implanted in the dominant eye and AT LISA tri implanted in the other eye. Dependence on spectacles, the occurrence of photic phenomena and patient and surgeon satisfaction with the patient's visual performance will be documented. Furthermore, the refraction data will be used to optimize the IOL constants for IOL power calculations.

Detailed description: An extended depth of field can enable patients to do most everyday tasks without glasses. Compared to MIOLs, side effects such as glare and halo perception are expected to be less frequent and with lower intensity. This study is designed to assess visual performance and satisfaction in patients who underwent bilateral AT LARA IOL implantation or a mixed implantation of AT LARA in the dominant eye and AT LISA tri in the non-dominant eye. All patients will be offered enrolment after successful implantation in both eyes. Therefore, the preoperative and surgical data are recorded retrospectively, the follow-up examinations will be documented prospectively. This approach is justified and does not cause bias, as the purpose of this study is to investigate the performance of the IOL after successful implantation and uncomplicated surgery.

In this retrospective/prospective, non-randomized study, subjects will receive either binocular implantation of AT LARA/AT LARA toric or AT LARA/AT LARA toric in the distance dominant eye and AT LISA tri/AT LISA tri toric in the non-dominant eye. The main outcome parameter is best corrected visual acuity (CDVA). Secondary outcome parameters are: preferred near and intermediate distance, UDVA, DCIVA (Salzburg Reading desk in preferred distance), DCNVA (Salzburg Reading Desk in preferred near distance), distance corrected intermediate and near visual acuity with different contrast settings (Salzburg Reading Desk), manifest refraction, monocular and binocular defocus curve analysis, dysphotopsia simulation (Halo \& Glare Simulator), subjective patient satisfaction (MacAlinden) questionnaire.

Patients have different demands for intermediate and near vision as well as distances needed for daily routine. Comparing both groups indicates there is individual lens fitting for patients depending on their own needs. Subjects are to be evaluated 2-4 months and 5-8 months after implantation of either configuration.

Eligibility criteria: Inclusion Criteria:

* Patients bilaterally implanted with the AT LARA IOL or the AT LARA and AT LISA tri IOLs or their toric versions
* Age 18 and older
* Uncomplicated implantation of study IOLs
* No visual acuity limiting pathologies
* Clear intraocular media
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Written informed consent for participation in the study and data protection

Exclusion Criteria:

* Visual potential of less than 0.63 (decimal) in each eye due to ocular pathologies, e.g. retinal disorders
* Postoperative CDVA \>0.2 log MAR
* Visual field loss which has impact on visual acuity
* Use of systemic or ocular medication that might affect vision
* Acute or chronic disease, illness, ocular trauma or surgery that would confound results (e.g. macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
* Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus
* Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
* Patient participates in other clinical trial (former participation is no exclusion criterion)

Primary outcomes:
measure: Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: Pre-op, 2-4 Months, & 5-8 Months
Secondary outcomes:
measure: Postoperative uncorrected monocular and binocular distance visual acuity
timeFrame: 2-4 Months, & 5-8 Months
measure: Postoperative uncorrected and distance-corrected binocular near visual acuity
timeFrame: 2-4 Months, & 5-8 Months
measure: Postoperative uncorrected and distance-corrected binocular intermediate visual acuity
timeFrame: 2-4 Months, & 5-8 Months
measure: Reading speed and acuity, and preferred reading distance (Salzburg reading desk)
timeFrame: 2-4 Months, & 5-8 Months
measure: Postoperative use of spectacles (near, intermediate, distance)
timeFrame: 2-4 Months, & 5-8 Months
measure: Photic phenomena
timeFrame: 2-4 Months, & 5-8 Months
measure: Defocus curve
timeFrame: 2-4 Months, & 5-8 Months
measure: Patient satisfaction
timeFrame: 2-4 Months, & 5-8 Months
measure: Surgeon's assessment
timeFrame: 2-4 Months, & 5-8 Months
measure: Optimization of IOL-constants
timeFrame: 2-4 Months, & 5-8 Months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Hellerup Øjenklinik
city: Frankfurt
country: Germany
facility: Goethe University
city: Rheine
country: Germany
facility: Augentagesklinik Rheine
city: Belfast
country: Ireland
facility: Cathedral Eye Clinic
Study officials:
affiliation: Augentagesklinik Rheine
name: Florian Kretz
role: PRINCIPAL_INVESTIGATOR
References: