EDOF and Multifocal IOL Study

NCT05573529 | Completed

• 1 other identifier: 1163/2020
• Study Type: interventional
• Target: 50
• 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 Cataract

Outcome Measures

Primary Outcomes (1)

• distant corrected near visual acuity

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

  6 months

Other Outcomes (1)

• Binocular Uncorrected Near Visual Acuity

  3 years

Study Arms (2)

Edof IOL vs. multifocal 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 Edof IOL one (I) vs. multifocal IOL one (I).

Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation

Edof IOL vs. multifocal 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 two (II) participants will receive Edof IOL one (I) vs. multifocal IOL two (II).

Procedure: phacoemulsification and intraocular lens implantation; Device: 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

Edof IOL vs. multifocal IOL I; Edof IOL vs. multifocal IOL II

intraocular lens implantation DEVICE

intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification

Edof IOL vs. multifocal IOL I; Edof IOL vs. multifocal IOL II

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
• Age 50-90
• Visual potential in both eyes of 20/30 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

You may not qualify if:

• Preceding ocular surgery or trauma
• Relevant other ophthalmic diseases (such as retinal degenerations, etc.)
• Uncontrolled systemic or ocular disease

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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 two groups recieving predefined EDOF and multifocal intraocular lenses. In group one (I), the EDOF lens one (I) will be implanted in the dominant eye and the multifocal lens one (I) in the non-dominant eye. Subsequently, study participants in group two (II) will receive the EDOF lens one (I) in the dominant eye and the multifocal lens two (II) in the non-dominant eye.

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: October 10, 2022
• Study Start: November 9, 2020
• Primary Completion: March 23, 2023
• Study Completion: February 5, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

AU (1)