Posterior Capsule Opafication of Two Different Hydrophobi... | NCT04196673

Studies
Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

NCT04196673

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Dec 12, 2019Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Age Related Cataracts

Interventions

Alcon SN60WF
Hoya Vivinex

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2015Actual

Primary Completion Date

Jun 19, 2016Actual

Completion Date

Aug 23, 2019Actual

First Submitted Date

Dec 6, 2019

First Submission Date that Met QC Criteria

Dec 11, 2019

First Posted Date

Dec 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2019

Last Update Posted Date

Dec 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alcon SN60WF	Experimental	Implantation of an intraocular lens Alcon SN60WF	Device: Alcon SN60WF
Hoya Vivinex	Experimental	Implantation of an intraocular lens Hoya Vivinex	Device: Hoya Vivinex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alcon SN60WF	Device	Implantation of an intraocular lens Alcon SN60WF	Alcon SN60WF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupert Menapace, Prof. Dr.	Medical University of Vienna	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.