Evaluation of Long-Term Clinical Acceptability and Satisf... | NCT03314766

Studies
Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

NCT03314766

Sponsor

AcuFocus, Inc.

Status

Completed

Last Update Posted

May 13, 2022Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Cataract
Presbyopia

Interventions

IC-8 IOL

Countries

Germany
Italy
Norway
Spain

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

Oct 20, 2017Actual

Primary Completion Date

Nov 27, 2018Actual

Completion Date

Nov 27, 2018Actual

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 19, 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

May 12, 2022

Last Update Posted Date

May 13, 2022Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

Detailed Description

This will be a prospective, multi-center, non-interventional study in up to 80 patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029 at up to nine clinical sites within Europe.

The purpose of this study is to demonstrate the long-term clinical acceptability and overall satisfaction in patients implanted with the IC-8 IOL. The primary study endpoint is binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients at least 12 months post-implantation. The secondary study endpoint is overall satisfaction with postoperative vision in 85% or more patients reporting either satisfied or very satisfied at least 12 months post-implantation.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IC-8 IOL		Patients previously implanted with an IC-8 IOL contralaterally or bilaterally under the protocol ACU-P14-029	Device: IC-8 IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IC-8 IOL	Device	Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TCNVA	Binocular target-corrected near visual acuity (TCNVA) of 20/32 or better in 85% or more patients.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Satisfaction	Overall satisfaction with postoperative vision at least 12 months post-operatively, with an outcome of objective of 85% or more being either very satisfied or satisfied.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients previously implanted contralaterally or bilaterally with the IC-8 IOL under the protocol ACU-P14-029 and have had the IOL implanted for a duration of at least 12 months and currently have the IC-8 IOL in the eye.
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures at the study visit.
Signed informed consent.

Exclusion Criteria:

1. Patients who have developed systemic or ocular pathology, not related to the IOL that affected their best corrected distance visual acuity to be 0.8 decimal or worse as determined by diagnostic testing or investigator's medical judgment. -

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 for this study will be recruited from the clinical sites that participated in the prior open-label, multicenter study (protocol ACU-P14-029). Anticipated study sample size of no more than 80 patients should effectively demonstrate the long-term clinical acceptability of the IC-8 IOL implanted in aphakic patients.

Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Nicholas Tarantino, OD		Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Augen Zentrum Nordwest		Ahaus		48683	Germany
Universitats-Augenklinik, Department of Ophthalmology

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

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012030	Refractive Errors

ID	Term
D002386	Cataract
D011305	Presbyopia