Compare Visual Outcomes Using a New Diagnostic Device | NCT04037631

Studies
Compare Visual Outcomes Using a New Diagnostic Device

NCT04037631

Sponsor

Carl Zeiss Meditec AG

Status

Terminated

Last Update Posted

Jan 28, 2021Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Presbyopia

Interventions

Diagnostic device

Countries

Germany

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment

Expanded Access Info

Start Date

Jul 20, 2017Actual

Primary Completion Date

May 1, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Jul 26, 2019

First Submission Date that Met QC Criteria

Jul 29, 2019

First Posted Date

Jul 30, 2019Actual

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

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients without clinically significant age-related cataract			Diagnostic Test: Diagnostic device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic device	Diagnostic Test	Diagnostic test	Patients without clinically significant age-related cataract

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corrected distance visual acuity (CDVA)	Evaluation of CDVA obtained with diagnostic device	3 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
Patients of any gender, aged 18 years to open age
Assured follow-up examinations
Healthy eyes without clinically significant age-related cataract

-Exclusion Criteria:
Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
Patients whose freedom is impaired by administrative or legal order
Concurrent participation in another drug or device investigation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients without clinically significant age-related cataract

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Internationale Innovative Ophthalmologie		Düsseldorf		40549	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39453845	Derived	Schallhorn SC, Fernandez J, Kaymak H, Gerlach M, Kirchner FO. Prediction of visual outcomes using virtual implantation of a trifocal intraocular lens in presbyopic lens exchange patients. J Cataract Refract Surg. 2025 Feb 1;51(2):133-140. doi: 10.1097/j.jcrs.0000000000001576.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases