EDOF and Multifocal IOL Study

Not Applicable

Completed

• Conditions: Age-related Cataract
• Interventions: Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation

• Registration Number: NCT05573529
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edof IOL vs. multifocal IOL I	intraocular lens implantation	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).
Edof IOL vs. multifocal IOL II	intraocular lens implantation	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).
Edof IOL vs. multifocal IOL I	phacoemulsification and intraocular lens implantation	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).
Edof IOL vs. multifocal IOL II	phacoemulsification and intraocular lens implantation	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).

Primary Outcome Measures

Name	Time	Method
distant corrected near visual acuity	6 months	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria