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

Primary Purpose

Age Related Cataracts

Status
Active
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Alcon Clareon
Hoya Vivinex
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age Related Cataracts

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Vienna Allgemeines Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Alcon Clareon

Hoya Vivinex

Arm Description

Implantation of an intraocular lens Alcon Clareon

Implantation of an intraocular lens Hoya Vivinex

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Acuity
UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
Fibrosis
grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Subjective glistening score
neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
YAG capsulotomy rate
described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no

Full Information

First Posted
April 27, 2020
Last Updated
May 16, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04369482
Brief Title
Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
Acronym
Clarinex
Official Title
Posterior Capsule Opafication of Different Hydrophobic Acrylic Intraocular Lenses: Vivinex iSert P261 vs.Clareon IOL
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcon Clareon
Arm Type
Active Comparator
Arm Description
Implantation of an intraocular lens Alcon Clareon
Arm Title
Hoya Vivinex
Arm Type
Active Comparator
Arm Description
Implantation of an intraocular lens Hoya Vivinex
Intervention Type
Device
Intervention Name(s)
Alcon Clareon
Intervention Description
Implantation of an intraocular lens Alcon Clareon
Intervention Type
Device
Intervention Name(s)
Hoya Vivinex
Intervention Description
Implantation of an intraocular lens Hoya Vivinex
Primary Outcome Measure Information:
Title
PCO score
Description
subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
UCDVA(uncorrected distance visual acuity), BCDVA (best corrected distance visual acuity)
Time Frame
3 years
Title
Fibrosis
Description
grade of fibrosis assessed subjectively at the slitlamp (grade 0=no fibrosis, grade 3=maximum fibrosis)
Time Frame
3 years
Title
Subjective glistening score
Description
neg, <10, 10-20, 20-30, 30-40, >40 uniform or localized
Time Frame
3 years
Title
YAG capsulotomy rate
Description
described subjectively at the slitlamp: was a YAG capsulotomy performed yes/no
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna Allgemeines Krankenhaus
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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