Influence of an Capsular Tension Ring on the Rotation of... | NCT02649257

Studies
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)

NCT02649257

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 12, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

cataract surgery
intraocular lens (MC 6125 AS)
capsular tension ring (CTR 13/11)

Countries

Austria

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

Jan 2016

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

Jul 2014

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Jan 6, 2016

First Posted Date

Jan 7, 2016Estimated

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

Jan 11, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Description Module

Brief Summary

The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 AS IOL.

At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MC 6125 AS IOL + CTR	Experimental	All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).	Procedure: cataract surgery Device: intraocular lens (MC 6125 AS) Device: capsular tension ring (CTR 13/11)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cataract surgery	Procedure		MC 6125 AS IOL + CTR
intraocular lens (MC 6125 AS)

Measure	Description	Time Frame
IOL rotation		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation

Exclusion Criteria:

Preceding ocular surgery or trauma
Recurrent intraocular inflammation of unknown etiology
Uncontrolled glaucoma
Uncontrolled systemic or ocular disease
Blind fellow eye
Microphthalmus
Corneal abnormality
History of uveitis/iritis
Iris neovascularization
Pseudoexfoliation
Proliferative diabetic retinopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology and Optometry of the Medical University Vienna		Vienna	Vianne	1090	Austria

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction
D007910	Lenses, Intraocular

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative
D007909	Lenses

Browse Leaves

Not provided

Browse Branches

Not provided