Clinical Analysis of Two Toric Intraocular Lenses | NCT03371576

Studies
Clinical Analysis of Two Toric Intraocular Lenses

NCT03371576

Sponsor

Hospital Hietzing

Status

Completed

Last Update Posted

Dec 13, 2017Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Cataract
IOL

Interventions

intraocular lenses

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 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

Jun 1, 2012Actual

Primary Completion Date

Aug 1, 2015Actual

Completion Date

Sep 1, 2017Actual

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Dec 12, 2017

First Posted Date

Dec 13, 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

Dec 12, 2017

Last Update Posted Date

Dec 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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: Comparison of two torical intraocular lenses with differents haptic design in patients with cataract.

Methods: In this prospective, randomized clinical trial 120 eyes of 60 patients underwent phacoemulsification. In patient's eyes the Tecnis torical IOL (Abbott Medical Optics) or the AT Torbi torical 709 MB IOL (Zeiss Medical AG) were randomly implanted. Three months after surgery visual acuity, rotation stability and astigmatism correction were evaluated.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
2 different torical intraocular lenses			Device: intraocular lenses

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
uncorrected visual acuity	visual acuity in logMARon an ETDRS Chart	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age related cataract on both eyes
Corneal astigmatism 1,0- 4,0 D
Potential postoperative visus 1,0
No other ocular pathology as cataract
Age 18 - 80
Written informed consent to surgery and participation in the study

Exclusion Criteria:

Pregnancy, breastfeeding
Amblyopy, diabetic retinopathy, uveitis or other relevant ophthalmologic diseases
Optical media disturbances due to: corneal and vitreal opacity, PEX
Irregular astigmatism measured with corneal topography (Visante-omni), keratoconus
≥ 10 degrees difference between the axis of keratometry measurement of the IOL Master and the simulated K reading of the corneal topograph (Visante-omni)
Trauma, ocular surgery performed within 6 months
Traumatic cataract
Potential postoperative visus under 1,0

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with cataract on both eyes.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29607216	Derived	Mihaltz K, Lasta M, Burgmuller M, Vecsei-Marlovits PV, Weingessel B. Comparison of Two Toric IOLs with Different Haptic Design: Optical Quality after 1 Year. J Ophthalmol. 2018 Feb 11;2018:4064369. doi: 10.1155/2018/4064369. eCollection 2018.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

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