Evaluation of Physiological Responses at the Anterior Sur... | NCT04230629

Studies
Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

NCT04230629

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Mar 9, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Age Related Cataracts

Interventions

Vivinex XY1
Vivinex XY1A

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2021Estimated

Primary Completion Date

Dec 30, 2021Estimated

Completion Date

Jun 30, 2022Estimated

First Submitted Date

Jan 10, 2020

First Submission Date that Met QC Criteria

Jan 14, 2020

First Posted Date

Jan 18, 2020Actual

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

Mar 8, 2021

Last Update Posted Date

Mar 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rupert Menapace, Clinical Professor, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

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 the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH.

A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) 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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vivinex XY1	Active Comparator	Implantation of an intraocular lens Hoya Vivinex XY1	Device: Vivinex XY1
Vivinex XY1A	Active Comparator	Implantation of an intraocular lens Hoya Vivinex XY1A	Device: Vivinex XY1A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vivinex XY1	Device	Implantation of an intraocular lens Hoya Vivinex XY1	Vivinex XY1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of FBGC (foreign body giant cells) (slitlamp examination)	The number of foreign body giant cells on the IOLs will be assessed.	5 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Monocytes (slitlamp examination)	The number of monocytes on the IOLs will be assessed. The following classification will be used: + = fewer than 10 cells/mm2; ++ = 10 to 25 cells/mm2; +++ = more than 25 cells/mm2	5 months
PCO Score (slitlamp examination)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
Age 40 and older
Astigmatism of at least 0.75Diopters in one eye
Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

Diabetes mellitus
Pseudoexfoliation syndrome
Systemical anticoagulation
Antiphlogistic therapy
Antiglaucomatosa
Uncontrolled systemic or ocular disease
Preceding ocular surgery or trauma
Intraoperative complications
Pregnancy/Nursing
Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rupert Menapace	Contact	0140400	66300	rupert.menapace@meduniwien.ac.at

Overall Officials

Not provided

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 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.