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CompletedNCT04196673AcryviviUpdated Dec 12, 2019

Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

An interventional study of Alcon SN60WF and Hoya Vivinex in Age Related Cataracts, sponsored by Medical University of Vienna. Completed. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-12-12.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Sep 2015, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years to 100 Years
Sex
All
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Study summary

On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.

A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.

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Conditions studied

  • Age Related Cataracts

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
  • Age 50 and older
  • Visual potential in both eyes of 20/30 or better as determined by investigators estimation
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion criteria

Exclusion Criteria:

  • Preceding intraocular surgery or ocular trauma
  • Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
  • Laser treatment
  • Uncontrolled systemic or ocular disease
  • Infectious disease
  • Pregnancy/Nursing
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Alcon SN60WF

    Implantation of an intraocular lens Alcon SN60WF

    Device: Alcon SN60WF

  • Experimental
    Hoya Vivinex

    Implantation of an intraocular lens Hoya Vivinex

    Device: Hoya Vivinex

Interventions

  • DeviceAlcon SN60WF

    Implantation of an intraocular lens Alcon SN60WF

  • DeviceHoya Vivinex

    Implantation of an intraocular lens Hoya Vivinex

06

What researchers measure

Primary outcomes

  1. PCO score

    subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)

    Time frame: 3 years

Secondary outcomes

  1. Visual Acuity

    UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)

    Time frame: 3 years

  2. Fibrosis

    grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)

    Time frame: 3 years

  3. Subjective glistening score

    neg, \<10, 10-20, 20-30, 30-40, \>40 uniform or localized

    Time frame: 3 years

  4. YAG capsulotomy rate

    described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04196673
Lead sponsor
Medical University of Vienna
Responsible party
Rupert Menapace (Clinical Professor, Medical University of Vienna) — Principal investigator
First posted
Dec 12, 2019
Start date
Sep 1, 2015
Primary completion
Jun 19, 2016
Completion
Aug 23, 2019
Last update
Dec 12, 2019

Study contacts

Rupert Menapace, Prof. Dr.
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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