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

Medical University of Vienna100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

100

Conditions

Age Related Cataracts

Interventions

Alcon ClareonDEVICE

Implantation of an intraocular lens Alcon Clareon

Hoya VivinexDEVICE

Implantation of an intraocular lens Hoya Vivinex

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna Allgemeines Krankenhaus

Vienna, Austria

Outcomes

Primary Outcomes

PCO score

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

Time frame: 3 years

Secondary Outcomes

Visual Acuity

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

Time frame: 3 years

Fibrosis

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

Time frame: 3 years

Subjective glistening score

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

Time frame: 3 years

YAG capsulotomy rate

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

Time frame: 3 years

Data from ClinicalTrials.gov

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