Intraindividual Comparison of EMO IOLs

NCT05822089 | Recruiting

• 1 other identifier: 1631/2021
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

Brief Summary

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

Conditions

Age Related Cataracts

Outcome Measures

Primary Outcomes (3)

• Distant corrected intermediate visual acuity

  Primary outcome measure will be monocular distant corrected intermediate visual acuity (DCIVA) of each intraocular lens implanted. DCIVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

  2-6 months

• Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL

  Primary outcome measure will be monocular best-corrected distance visual acuity (BCDVA) of each intraocular lens implanted in eyes with irregular astigmatism. BCDVA will be assessed using standardized early treatment diabetic retinopathy study (EDTRS) charts on a logarithm of the minimum angle of resolution (logMAR) scale.

  3-5 months

• Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1

  Primary outcome measures for arm ten (X) will be the distance corrected contrast sensitivity and near corrected reading ability and reading speed. Contrast sensitivity will be assessed under standard photopic (85cd/m2) and mesopic (3cd/m2) conditions

  2-6 months and 1-5 years

Secondary Outcomes (1)

• Contrast sensitivity and reading ability

  2-6 months and 1-5 years

Study Arms (10)

Monofocal IOL I vs. enhanced monofocal IOL I

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm one (I) participants will receive a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL II vs. enhanced monofocal IOL I

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm two (II) participants will receive a monofocal IOL (Sensar 1AAB00) vs. an enhanced monofocal IOL (ICB00)

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL III vs. enhanced monofocal IOL II

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm three (III) participants will receive a monofocal IOL (Vivinex XY1)vs. an enhanced monofocal IOL (Vivinex Impress).

Procedure: phacoemulsification and intraocular lens implantation

Enhanced monofocal IOL II vs. enhanced monofocal IOL II

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm four (IV) participants will receive an enhanced monofocal IOL (Vivinex Impress) bilateral with a monovision target

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL IV vs. enhanced monofocal IOL III

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm five (V) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)

Procedure: phacoemulsification and intraocular lens implantation

Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatism

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm six (VI) participants will receive an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed.

Procedure: phacoemulsification and intraocular lens implantation

Extended Depth of Focus IOL in eyes with irregular astigmatism

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm seven (VII) participants will receive an extended depth of focus IOL (IC-8 Apthera IOL) in one eye if irregular astigmatism is observed.

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL IV vs. enhanced monofocal IOL IV

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm eight (VIII) participants will receive an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)

Procedure: phacoemulsification and intraocular lens implantation

Enhanced depth of focus IOL I vs. Enhanced depth of focus IOL I

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm nine (IX) participants will receive an enhanced depth of focus IOL (PureSee) bilateral with a monovision target.

Procedure: phacoemulsification and intraocular lens implantation

Monofocal IOL VI and monofocal IOL III

EXPERIMENTAL

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. In Arm ten (X) participants will receive a monofocal IOL (Vivinex XC1) bilateral or a monofocal IOL (Vivinex XY1) bilateral.

Procedure: phacoemulsification and intraocular lens implantation

Interventions

phacoemulsification and intraocular lens implantation PROCEDURE

bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (ZCB00) vs. an enhanced monofocal IOL (ICB00)

Monofocal IOL I vs. enhanced monofocal IOL I

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral age-related cataract planned for phacoemulsification extraction and posterior IOL implantation
• Age 50 to 100
• Visual potential in both eyes of 20/25 or better as determined by investigators estimation
• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
• Irregular Astigmatism (Acrysof IQ Vivity IOL, IC-8 Apthera IOL)
• postoperativ binocular best corrected distance visual acuity (BCVA) ≥ 1.0 decimal (Arm ten (X))
• Standard cataract surgery with bilateral implantation of a monofocal IOL (Vivinex XC1 or Vivinex XY1) (Arm ten (X))

You may not qualify if:

• Preceding intraocular surgery or ocular trauma
• Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe pseudoexfoliation syndrome, preceding cryocoagulation, trauma)
• Pupil diameter \< 2.0 mm (photopic)
• Laser treatment
• Uncontrolled systemic or ocular disease
• Pregnancy/Nursing
• childbearing ability

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Interventions

Phacoemulsification; Lens Implantation, Intraocular

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Christina Leydolt, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Leydolt, MD

CONTACT

+43 (01) 40 400 79480; christina.leydolt@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor will be masked to the intraocular lens implanted
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr

Model Details: Intra-individual comparison of 7 groups receiving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: December 13, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

AU (1)