Optical Quality After Implantation of a Spherical or Asph... | NCT01995630

Studies
Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

NCT01995630

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Jun 28, 2017Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Cataract
Spherical Aberrations
Intraocular Lenses
Depth of Focus

Interventions

AMO Tecnis ZA9003
AMO Sensar AR40e

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

Jun 2017

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

Nov 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 26, 2016Actual

First Submitted Date

Nov 21, 2013

First Submission Date that Met QC Criteria

Nov 21, 2013

First Posted Date

Nov 26, 2013Estimated

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

Jun 27, 2017

Last Update Posted Date

Jun 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Navid Ardjomand, Univ.-Doz. Dr. med. univ., Medical University of GrazPrincipal Investigator

Lead Sponsor

Medical University of GrazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypermetropic, spherical IOL	Experimental	AMO Sensar AR40e	Device: AMO Sensar AR40e
Hypermetropic, aspheric IOL	Experimental	AMO Tecnis ZA9003	Device: AMO Tecnis ZA9003
Emmetropic, spherical IOL	Active Comparator	AMO Sensar AR40e	Device: AMO Sensar AR40e
Emmetropic, aspheric IOL	Active Comparator	AMO Tecnis ZA9003	Device: AMO Tecnis ZA9003

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMO Tecnis ZA9003	Device		Emmetropic, aspheric IOL Hypermetropic, aspheric IOL
AMO Sensar AR40e

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distance-corrected intermediate visual acuity		3 month postop

Secondary Outcomes

Measure	Description	Time Frame
Distance-corrected near visual acuity		3 month postop
Uncorrected distance visual acuity		3 month postop
Corrected distance visual acuity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cataract
Dioptric power of IOL >22.0 D in hypermetropic patients and 18.0-22.0 D in emmetropic patients, respectively

Exclusion Criteria:

Uveitis, pathology of the retina or the optic nerve
Corneal scarring or irregularities
Astigmatism >1.5 D
Amblyopia
Perioperative complications
Postoperative refractive error >2.0 D of spherical equivalent
Postoperative DCVA <0.8 (ETDRS)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 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
Navid Ardjomand, MD	Dept. of Ophthalmology, Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Ophthalmology, Medical University of Graz		Graz		8036	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