Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

Age Related Cataracts Clinical Trial

— Acryvivi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196673
• Other study ID #: 1560/2014
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: August 23, 2019

Study information

• Verified date: December 2019
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 23, 2019
• Est. primary completion date: June 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 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 SN60WF
Implantation of an intraocular lens Alcon SN60WF
• Hoya Vivinex
Implantation of an intraocular lens Hoya Vivinex

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

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