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Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses (Acryvivi)

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Medical University of Vienna

Status

Completed

Conditions

Age Related Cataracts

Treatments

Device: Hoya Vivinex
Device: Alcon SN60WF

Study type

Interventional

Funder types

Other

Identifiers

NCT04196673
1560/2014

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

50 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Alcon SN60WF
Experimental group
Description:
Implantation of an intraocular lens Alcon SN60WF
Treatment:
Device: Alcon SN60WF
Hoya Vivinex
Experimental group
Description:
Implantation of an intraocular lens Hoya Vivinex
Treatment:
Device: Hoya Vivinex

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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