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

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

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.

Study Overview

• Status: Completed
• Conditions: Age Related Cataracts
• Intervention / Treatment: Device: Hoya Vivinex; Device: Alcon SN60WF

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCO score	subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): June 19, 2016
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1560/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No