Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL (Clarinex)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369482
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Rupert Menapace, Medical University of Vienna

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 Clareon, 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
Age Related Cataracts Device: Alcon Clareon Device: Hoya Vivinex Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2023

Arm Intervention/treatment
Active Comparator: Alcon Clareon
Implantation of an intraocular lens Alcon Clareon
Device: Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex

Active Comparator: Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex
Device: Alcon Clareon
Implantation of an intraocular lens Alcon Clareon




Primary Outcome Measures :
  1. PCO score [ Time Frame: 3 years ]
    subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369482


Locations
Layout table for location information
Austria
Medical University of Vienna Allgemeines Krankenhaus
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Layout table for additonal information
Responsible Party: Rupert Menapace, Clinical Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04369482    
Other Study ID Numbers: Clarinex 1560/2014
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases