Combined EDOF / Trifocal

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).

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: AT LARA IOL; Device: AT LISA Tri IOL

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark
    • Hellerup Øjenklinik
• Germany
  • Frankfurt, Germany
    • Goethe University
  • Rheine, Germany, 48429
    • Augentagesklinik Rheine
• Ireland
  • Belfast, Ireland
    • Cathedral Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Binocular EDOF IOL; Binocular EDOF IOL for treatment of cataract	Device: AT LARA IOL; EDOF IOL for treatment of cataract
Experimental: Combined Edof and Trifocal IOL; Combined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye	Device: AT LARA IOL; EDOF IOL for treatment of cataract; Device: AT LISA Tri IOL; Trifocal IOL for treatment of cataract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preoperative and postoperative binocular Corrected Distance Visual Acuity (CDVA)	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	Pre-op, 2-4 Months, & 5-8 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative uncorrected monocular and binocular distance visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular near visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Postoperative uncorrected and distance-corrected binocular intermediate visual acuity	The uncorrected and best corrected distance visual acuity is determined with standard reading charts at a distance of 4 or 5 m; logMar visual acuity is recorded. Near visual acuity (40 cm) and intermediate visual acuity (67 cm) are documented using suitable visual acuity charts for the respective distance or converted using conversion tables. The logMar visual acuity is recorded. Uncorrected visual acuity will be scored for distance, intermediate and near vision: logMAR 0.0 or better = 5; logMar 0.1 = 4; logMar 0.2 = 3; logMar 0.3 = 2; logMAR worse than 0.3 = 1 Scores for the individual distances will be added to a total score.	2-4 Months, & 5-8 Months
Reading speed and acuity, and preferred reading distance (Salzburg reading desk)	Sites at which the Salzburg Reading Desk is available will examine reading speed and acuity at 40 cm and 66 cm at the two postoperative visits. The following parameters will be documented: words per minute (WPM), characters per minute (CPM), words missed (reading speed recalculated when missed words are selected), LogMAR reading acuity, average reading distance, average reading time.	2-4 Months, & 5-8 Months
Postoperative use of spectacles (near, intermediate, distance)	The surgeon asks: "How often do you need glasses for near/intermediate/distance vision?". The answers are classified into 0%, 25%, 50%, 75% and 100% of the total time.	2-4 Months, & 5-8 Months
Photic phenomena	The McAlinden Quality of Vision (QoV) questionnaire will be used to assess the size and intensity of halo and glare	2-4 Months, & 5-8 Months
Defocus curve	Best-corrected distance defocus curve testing from +1.0 D to -4.0 D shall be performed. The image shall be defocused in -0.5 D increments with spherical minus lenses and a visual acuity measurement is obtained at each defocus increment.	2-4 Months, & 5-8 Months
Patient satisfaction	The McAlinden Quality of Vision (QoV) questionnaire will be used to assess patient satisfaction. Patients are asked two closed answered questions, with Yes or No being the answer. 'Would you decide to have multifocal IOLs again?' and ' Would you recommend the same lens to your relatives and friends?'	2-4 Months, & 5-8 Months
Surgeon's assessment	The surgeon completes a short questionnaire on the handling and performance of the lens. The ease of implantation, achievement of the target refraction, satisfaction with the patient's vision and general satisfaction are recorded.	2-4 Months, & 5-8 Months
Optimization of IOL-constants	For this purpose, the corneal radii, the axial length, the measured anterior chamber depth and the implanted IOL power are recorded during biometry to determine the correct IOL power. Postoperatively, the subjective refraction achieved is documented as spherical equivalent and forwarded to Prof. Dr. Achim Langenbucher, Medical Faculty of Saarland University, Experimental Ophthalmology, for evaluation with the IOL-Con software	2-4 Months, & 5-8 Months

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG
• Investigators: Principal Investigator: Florian Kretz, Augentagesklinik Rheine

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-LARALISA-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No