Binocular Custom Vision Utilizing The Light Adjustable Le... | NCT04533191

Studies
Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

NCT04533191

Sponsor

Vance Thompson Vision

Status

Completed

Last Update Posted

May 20, 2024Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Cataract
Pseudophakia

Interventions

LAL IOL lens

Countries

United States

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 2024

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

Sep 1, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 31, 2020Actual

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 16, 2024

Last Update Posted Date

May 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects treated with LAL lens		Subjects that underwent standard of care cataract surgery and LAL IOL placement.	Procedure: LAL IOL lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LAL IOL lens	Procedure	Standard of care Cataract surgery with IOL placement	Subjects treated with LAL lens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binocular uncorrected distance, intermediate, and near visual acuity		Through Month one post-op
Binocular uncorrected depth of focus		Through Month one post-op

Secondary Outcomes

Measure	Description	Time Frame
Manifest refraction		Through Month one post-op
Monocular uncorrected distance visual acuity		Through Month one post-op
Monocular best corrected distance visual acuity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients able to sign informed consent
Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.

Exclusion Criteria:

Inability to sign informed consent
Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
Unable to return for light treatments

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vance Thompson Vision		Sioux Falls	South Dakota	57108	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D019591	Pseudophakia

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided