Spherical Aberration on the Optical of Two Different Asph... | NCT03224728

Studies
Spherical Aberration on the Optical of Two Different Aspherical Intraocular Lenses

NCT03224728

Sponsor

Hospital Hietzing

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Cataract

Interventions

intraocular lens

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

Jul 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

Sep 2015Actual

Primary Completion Date

Jun 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 21, 2017Actual

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

Jul 17, 2017

Last Update Posted Date

Jul 21, 2017Actual

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

Purpose: To compare the effect of spherical aberration on optical quality in eyes with two different aspherical intraocular lenses Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes an aberration-free aspherical IOL (Aspira-aA; Human Optics) or an aberration-correcting aspherical IOL (Tecnis ZCB00; Abott Medical Optics) were randomly implanted. Three months after surgery visual acuity, contrast sensitivity, wavefront measurements with iTrace as well as tilt and decentration measurements with Visante anterior segment OCT were performed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2 different Intraocular lenses		2 different intraocular lenses were compared	Device: intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraocular lens	Device		2 different Intraocular lenses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modulation transfer function (MTF) at 3 months after surgery		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Bilateral age-related cataract
Potential postoperative visual acuity of 1.0 Snellen
No relevant ocular pathology other than cataract
Written informed consent to surgery and participation in the study

Exclusion Criteria:

Amblyopia, diabetic retinopathy, uveitis or other relevant ophthalmic diseases
Optical media disturbances due to: corneal and vitreal opacity, PEX
Preceding ocular trauma or ocular surgery within 6 months
Inability to cooperate
Pregnancy (a pregnancy test will be performed preoperatively in women of reproductive age)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Men and women between 50 and 85 years with age related cataract

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28900544	Derived	Lasta M, Mihaltz K, Kovacs I, Vecsei-Marlovits PV. Effect of Spherical Aberration on the Optical Quality after Implantation of Two Different Aspherical Intraocular Lenses. J Ophthalmol. 2017;2017:8039719. doi: 10.1155/2017/8039719. Epub 2017 Aug 16.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

ID	Term
D007909	Lenses
D055096	Optical Devices
D004864	Equipment and Supplies
D019736	Prostheses and Implants