EDOF and Multifocal IOL Study

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05573529
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cataract	Procedure: phacoemulsification and intraocular lens implantation; Device: intraocular lens implantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: Single (Outcomes Assessor)
• Masking Description: outcome assessor will be masked to the intraocular lens implanted.
• Primary Purpose: Treatment
• Official Title: Comparison of Visual Outcomes and Patient Satisfaction After Bilateral Implantation of EDOF and Multifcoal IOLs- a Prospective Randomized Controlled Trial
• Actual Study Start Date: Nov 9, 2020
• Anticipated Primary Completion Date: May 8, 2023
• Anticipated Study Completion Date: May 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edof IOL vs. multifocal IOL I 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; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation; Device: intraocular lens implantation; intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification
Experimental: Edof IOL vs. multifocal IOL II 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; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation; Device: intraocular lens implantation; intraocular lens implantation includes EDOF IOL implantation in the dominant eye and multifocal IOL implantation in the non-dominant eye after phacoemulsification

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion Criteria:

• Preceding ocular surgery or trauma

• Relevant other ophthalmic diseases (such as retinal degenerations, etc.)

• Uncontrolled systemic or ocular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christina Leydolt, Assoc. Prof. PD Dr, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05573529
• Other Study ID Numbers: 1163/2020
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 13, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Oct 13, 2022