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Acryvivi: Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04196673
Collaborator
(none)
80
Enrollment
2
Arms
47.7
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Alcon SN60WF
  • Device: Hoya Vivinex
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.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 on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs. Acrysof SN60WF
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 19, 2016
Actual Study Completion Date :
Aug 23, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alcon SN60WF

Implantation of an intraocular lens Alcon SN60WF

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

Implantation of an intraocular lens Hoya Vivinex

Device: Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex

Outcome Measures

Primary Outcome Measures

  1. PCO score [3 years]

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

Secondary Outcome Measures

  1. Visual Acuity [3 years]

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

  2. Fibrosis [3 years]

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

  3. Subjective glistening score [3 years]

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

  4. YAG capsulotomy rate [3 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 100 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Rupert Menapace, Prof. Dr., Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rupert Menapace, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT04196673
Other Study ID Numbers:
  • 1560/2014
First Posted:
Dec 12, 2019
Last Update Posted:
Dec 12, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Dec 12, 2019