Project Bidof - Monovision by Pairing Bifocal and EDOF Lens | NCT05303571

Studies
Project Bidof - Monovision by Pairing Bifocal and EDOF Lens

NCT05303571

Sponsor

Johannes Kepler University of Linz

Status

Withdrawn

Last Update Posted

Mar 7, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cataract Senile

Interventions

Not provided

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not feasible

Expanded Access Info

Start Date

Mar 14, 2022Actual

Primary Completion Date

Mar 14, 2023Actual

Completion Date

Mar 14, 2023Actual

First Submitted Date

Mar 22, 2022

First Submission Date that Met QC Criteria

Mar 22, 2022

First Posted Date

Mar 31, 2022Actual

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

Mar 5, 2024

Last Update Posted Date

Mar 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthias Bolz, Head of Ophtalmology, Johannes Kepler University of LinzPrincipal Investigator

Lead Sponsor

Johannes Kepler University of LinzOTHER

Collaborators

Not provided

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

Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monodof		monofocal and EDOF lens
Bidof		Bifocal and EDOF lens

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distance Visual Acuity	percentage of patients with binocular distance corrected visual acuity of logMAR > 0.2	6 months
Intermediate Visual Acuity	percentage of patients with binocular intermediate distance corrected visual acuity of logMAR > 0.2	6 months
Near Visual Acuity	percentage of patients with binocular near visual acuity logmar < 0.2	6 months

Secondary Outcomes

Measure	Description	Time Frame
contrast vision	contrast sensitivity vision	3 months
Halo and Glare	Halo and Glare Simulator	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 21 and 99 years
signed informed consent form
condition after cataract surgery

Exclusion Criteria:

no signed informed consent form
laser treatment of the Cornea
macular pathologies
corneal pathologies
irregular astigmatism
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patient between 21 and 99 years after cataract surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johannes Kepler University		Linz	Upper Austria	4020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided