Combined EDOF / Trifocal

NCT ID: NCT05462067

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2020-11-20

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.

Conditions

Cataract

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Binocular EDOF IOL

Binocular EDOF IOL for treatment of cataract

Group Type: ACTIVE_COMPARATOR

AT LARA IOL

Intervention Type: DEVICE

EDOF IOL for treatment of cataract

Combined Edof and Trifocal IOL

Combined EDOF and Trifocal IOL - EDOF in the distance dominant eye / Trifocal in the non-dominant eye

Group Type: EXPERIMENTAL

AT LARA IOL

Intervention Type: DEVICE

EDOF IOL for treatment of cataract

AT LISA Tri IOL

Intervention Type: DEVICE

Trifocal IOL for treatment of cataract

Interventions

AT LARA IOL

EDOF IOL for treatment of cataract

Intervention Type: DEVICE

AT LISA Tri IOL

Trifocal IOL for treatment of cataract

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florian Kretz

Role: PRINCIPAL_INVESTIGATOR

Augentagesklinik Rheine

Locations

Hellerup Øjenklinik

Hellerup, , Denmark

Goethe University

Frankfurt, , Germany

Augentagesklinik Rheine

Rheine, , Germany

Cathedral Eye Clinic

Belfast, , Ireland

Countries

Denmark; Germany; Ireland

References

Moore J, Ostergaard J, Kretz F. Visual performance and patient preference with bilateral implantation of an extended depth of focus or combined implantation of an extended depth of focus/trifocal intraocular lens. Int Ophthalmol. 2024 Feb 14;44(1):80. doi: 10.1007/s10792-024-03030-y.

Reference Type: DERIVED

PMID: 38356027 (View on PubMed)

Other Identifiers

GPAS-LARALISA-2018-01

Identifier Type: -

Identifier Source: org_study_id