Skip to main content
OpenTrials
Completed

NCT Number: NCT04196673

Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age Related Cataracts

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Alcon SN60WF

Device

Implantation of an intraocular lens Alcon SN60WF

Hoya Vivinex

Device

Implantation of an intraocular lens Hoya Vivinex

Primary outcomes

  1. PCO score

    Time frame: 3 years

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

Secondary outcomes

  1. Visual Acuity

    Time frame: 3 years

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

  2. Fibrosis

    Time frame: 3 years

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

  3. Subjective glistening score

    Time frame: 3 years

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

  4. YAG capsulotomy rate

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF

Acronym: Acryvivi

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Dec 12, 2019
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.