Combined EDOF / Trifocal

NCT05462067 | Completed

• 1 other identifier: GPAS-LARALISA-2018-01
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 4

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Postoperative uncorrected monocular and binocular distance visual acuity

  2-4 Months, & 5-8 Months

• Postoperative uncorrected and distance-corrected binocular near visual acuity

  2-4 Months, & 5-8 Months

• Postoperative uncorrected and distance-corrected binocular intermediate visual acuity

  2-4 Months, & 5-8 Months

• Reading speed and acuity, and preferred reading distance (Salzburg reading desk)

  2-4 Months, & 5-8 Months

• Postoperative use of spectacles (near, intermediate, distance)

  2-4 Months, & 5-8 Months

Study Arms (2)

Binocular EDOF IOL

ACTIVE COMPARATOR

Binocular EDOF IOL for treatment of cataract

Device: AT LARA IOL

Combined Edof and Trifocal IOL

EXPERIMENTAL

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

Device: AT LARA IOL; Device: AT LISA Tri IOL

Interventions

AT LARA IOL DEVICE

EDOF IOL for treatment of cataract

Binocular EDOF IOL; Combined Edof and Trifocal IOL

AT LISA Tri IOL DEVICE

Trifocal IOL for treatment of cataract

Combined Edof and Trifocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (4)

Hellerup Øjenklinik

Hellerup, Denmark

Location

Goethe University

Frankfurt, Germany

Location

Augentagesklinik Rheine

Rheine, 48429, Germany

Location

Cathedral Eye Clinic

Belfast, Ireland

Location

Related Publications (1)

• 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.

  PMID: 38356027 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Florian Kretz

  Augentagesklinik Rheine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 18, 2022
• Study Start: March 14, 2019
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); DK (1); DE (2)