Clinical Safety and Efficacy of Hydrophilic Acrylic Intra... | NCT03145103

Studies
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses

NCT03145103

Sponsor

Carl Zeiss Meditec AG

Status

Completed

Last Update Posted

Jul 18, 2018Actual

Enrollment

282Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

CT ASPHINA 409

Countries

Sweden

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 2018

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

Aug 7, 2017Actual

Primary Completion Date

Jun 26, 2018Actual

Completion Date

Jun 26, 2018Actual

First Submitted Date

May 5, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 9, 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, 2018

Last Update Posted Date

Jul 18, 2018Actual

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

282Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
409M	Experimental	CT ASPHINA 409M IOL	Device: CT ASPHINA 409

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT ASPHINA 409	Device	intraocular lens	409M

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	Monocular best corrected distance visual acuity	12 to 18 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
Assured follow-up examinations
Biometry measurement preferably compatible with the IOLMaster evaluation;
IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion Criteria:

BCVA not available preoperatively or better than 0.3 logMAR pre-op
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

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology		Linköping		SE58252	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32527240	Derived	Johansson B, Daniel ACS, Herbers C, Gerl M, Kretz FTA. Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study. BMC Ophthalmol. 2020 Jun 11;20(1):224. doi: 10.1186/s12886-020-01493-y.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases