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

Not Applicable

• Conditions: Age Related Cataracts
• Interventions: Device: Hoya Vivinex; Device: Alcon Clareon

• Registration Number: NCT04369482
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-12-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alcon Clareon	Hoya Vivinex	Implantation of an intraocular lens Alcon Clareon
Hoya Vivinex	Alcon Clareon	Implantation of an intraocular lens Hoya Vivinex

Primary Outcome Measures

Name	Time	Method
PCO score	3 years	subjectively and objectively graded: 0-10 (0= no PCO, 10= maximum PCO)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna Allgemeines Krankenhaus; 🇦🇹 Vienna, Austria