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Intraindividual Comparison of EMO IOLs

ConditionAge Related Cataracts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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 implantation

    Procedure/Surgery

    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 implantation

    Procedure/Surgery

    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)

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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)

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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)

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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

  • phacoemulsification and intraocular lens implantation

    Procedure/Surgery

    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

Treatment groups

461 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Monofocal IOL I vs. enhanced monofocal IOL IExperimental treatment 1 intervention
Group B: Monofocal IOL II vs. enhanced monofocal IOL IExperimental treatment 1 intervention
Group C: Monofocal IOL III vs. enhanced monofocal IOL IIExperimental treatment 1 intervention
Group D: Enhanced monofocal IOL II vs. enhanced monofocal IOL IIExperimental treatment 1 intervention
Group E: Monofocal IOL IV vs. enhanced monofocal IOL IIIExperimental treatment 1 intervention
Group F: Extended depth of focus IOL IV in eyes with low to moderate irregular astigmatismExperimental treatment 1 intervention
Group G: Extended Depth of Focus IOL in eyes with irregular astigmatismExperimental treatment 1 intervention
Group H: Monofocal IOL IV vs. enhanced monofocal IOL IVExperimental treatment 1 intervention
Group I: Enhanced depth of focus IOL I vs. Enhanced depth of focus IOL IExperimental treatment 1 intervention
Group J: Monofocal IOL VI and monofocal IOL IIIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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

Other outcomes

Sponsors and contacts

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Medical University of Vienna

Lead sponsor

Source ClinicalTrials.gov
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