Intraindividual Comparison of EMO IOLs

N/ARecruitingNCT05822089

Medical University of Vienna461 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

461

Conditions

Age Related Cataracts

Interventions

phacoemulsification and intraocular lens implantationPROCEDURE

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)

phacoemulsification and intraocular lens implantationPROCEDURE

bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Sensar 1 AAB00) vs. an enhanced monofocal IOL (ICB00)

phacoemulsification and intraocular lens implantationPROCEDURE

bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) vs. an enhanced monofocal IOL (Vivinex impress)

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 * 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)) Exclusion Criteria: * 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

Locations (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 2-6 months and 1-5 years

Secondary Outcomes

Contrast sensitivity and reading ability

Secondary outcome measures 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.

Time frame: 2-6 months and 1-5 years

Central Contacts

Christina Leydolt, MD

CONTACT

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

Data from ClinicalTrials.gov

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