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

Age Related Cataracts Clinical Trial

— Clarinex  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04369482
• Other study ID #: Clarinex 1560/2014
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract

Intervention

Device:
• Alcon Clareon
Implantation of an intraocular lens Alcon Clareon
• Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex

Locations

Country	Name	City	State
Austria	Medical University of Vienna Allgemeines Krankenhaus	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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