Intraindividual Comparison of EMO IOLs

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05822089
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 27.6
• Patients Per Site Per Month: 9.1

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 Cataracts	Procedure: phacoemulsification and intraocular lens implantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intra-individual comparison of 5 groups recieving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocoll with one IOL type in the dominant eye and the other IOL type in the non- dominant eye.Intra-individual comparison of 5 groups recieving predefined monofocal and enhanced monofocal intraocular lenses (EMO IOLs). Investigated IOLs will be implanted subsequently according to the study protocoll with one IOL type in the dominant eye and the other IOL type 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 of Enhanced Monofocal Intraocular Lenses
• Actual Study Start Date: Dec 13, 2021
• Anticipated Primary Completion Date: Mar 31, 2024
• Anticipated Study Completion Date: Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monofocal IOL vs. enhanced monofocal 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 a monofocal IOL vs. an enhanced monofocal IOL.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Experimental: Monofocal IOL vs. enhanced monofocal 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 a monofocal IOL vs. an enhanced monofocal IOL.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Experimental: Monofocal IOL vs. enhanced monofocal IOL III 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 vs. an enhanced monofocal IOL.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Experimental: Monofocal IOL vs. enhanced monofocal IOL IV 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 a monofocal IOL vs. an enhanced monofocal IOL.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation
Experimental: Monofocal IOL vs. enhanced monofocal IOL V 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 vs. an enhanced monofocal IOL.	Procedure: phacoemulsification and intraocular lens implantation; bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation

Outcome Measures

Primary Outcome Measures

1. Distant corrected intermediate visual acuity [2-6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Preceding intraocular surgery or ocular trauma

• Relevant other ophthalmic diseases that particularly effects the zonular apparatus (such as severe PEX, preceding cryocoagulation, trauma)

• Pupil diameter < 2.0 mm (photopic)

• Laser treatment

• Uncontrolled systemic or ocular disease

• Pregnancy/Nursing

• childbearing ability

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Christina Leydolt, MD, Medical University of Vienna

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: NCT05822089
• Other Study ID Numbers: 1631/2021
• First Posted: Apr 20, 2023
• Last Update Posted: Apr 20, 2023
• Last Verified: Apr 1, 2023

• 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 Apr 20, 2023