Comparison of Viusal Outcomes After Implantation of the P... | NCT02426385

Studies
Comparison of Viusal Outcomes After Implantation of the POD 26% FineVision Toric (PhysIOL) and POD 26% Toric (PhysIOL)

NCT02426385

Sponsor

Beaver-Visitec International, Inc.

Status

Withdrawn

Last Update Posted

May 6, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cataract

Interventions

FineVision Toric

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

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of suitable patients

Expanded Access Info

Start Date

Apr 2015Actual

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Apr 21, 2015

First Submission Date that Met QC Criteria

Apr 21, 2015

First Posted Date

Apr 24, 2015Estimated

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

May 5, 2021

Last Update Posted Date

May 6, 2021Actual

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 study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC

Detailed Description

The study is an observational non-randomised controlled study comparing the visual acuity after implantation of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC This study includes both eyes of 24 patients implanted with the POD 26%FineVision Toric (group 1: 12 patients) and the POD 26% Toric (group 2: 12 patients) .

The study primary goal is to compare the near visual acuity in both groups. Distance and intermediate visual acuities, defocus curve, refraction and straylight will be compared.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1POD26PFT		Patients implanted with the POD 26% FineVision Toric	Device: FineVision Toric
2POD26PT		Patients implanted with the POD 26% Toric

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FineVision Toric	Device	Posterior chamber IOL which consists in a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The visual acuity at near of the POD 26% FINEVISION TORIC with respect to the POD 26% TORIC is improved of at least LogMAR 0.2.		3 months

Secondary Outcomes

Measure	Description	Time Frame
The secondary objective is to measure far and intermediate visual acuity, the refraction, centration, rotational stability and to determine the amount of photic phenomena for both IOLs: POD 26% FINEVISION TORIC and POD 26% TORIC.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient older than 50 years old
Regular corneal astigmatism >1.0 dioptres by IOL Master (regularity determined by the topography of the keratometry).
Regular corneal astigmatism <2.5 dioptres by IOL Master (regularity determined by the topography of the keratometry).
Group 1: patients after cataract surgery with Fine Vision toric implanted in both eyes
Group 2: patients after cataract surgery with Ankoris implanted in both eyes
Availability, willingness and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• - Irregular astigmatism

Difficulty for cooperation (distance from their home, general health condition)
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
Any ocular comorbidity
History of ocular trauma or prior ocular surgery including refractive procedures
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
IOL spherical equivalent power lower than 10 D or greater than 30D
Complicated surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pseudophakic patients implanted with one of the two IOLs

Sampling Method

Non-Probability Sample

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases