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Recruiting NCT05822089

Intraindividual Comparison of EMO IOLs

No phase Interventional Age Related Cataracts

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation, phacoemulsification and intraocular lens implantation.
Who it may be relevant to
Registry conditions: Age Related Cataracts. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Visual Outcomes of Enhanced Monofocal Intraocular Lenses

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.

Interventions

  • Procedure phacoemulsification and intraocular lens implantation
    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)
  • Procedure phacoemulsification and intraocular lens implantation
    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)
  • Procedure phacoemulsification and intraocular lens implantation
    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)
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (Vivinex impress) in both eyes
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced monofocal IOL (EnVista) vs. an enhanced monofocal IOL (LuxSmart)
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (Acrysof IQ Vivity) in both eyes if low to moderate irregular astigmatism is observed
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an extended depth of focus IOL (IC-8 Apthera) in one eye if irregular astigmatism is observed
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (EnVista) vs. an enhanced monofocal IOL (EnVista Aspire)
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of an enhanced depth of focus IOL (PureSee) in both eyes
  • Procedure phacoemulsification and intraocular lens implantation
    bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (Vivinex XY1) in both eyes or a monofocal IOL (Vivinex XC1) in both eyes

Primary outcome measures

  • Distant corrected intermediate visual acuity [Time frame: 2-6 months]
  • Best-corrected distance visual acuity (BCDVA) - Acrysof IQ Vivity IOL, IC-8 Apthera IOL [Time frame: 3-5 months]
  • Contrast sensitivity and reading ability - Vivinex XC1 and Vivinex XY1 [Time frame: 2-6 months and 1-5 years]
Secondary outcome measures (1)
  • Contrast sensitivity and reading ability [Time frame: 2-6 months and 1-5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Identifiers

NCT: NCT05822089 · 1631/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗