Vivity Outcomes in Patients With Early Stage Glaucoma | NCT04670575

Studies
Vivity Outcomes in Patients With Early Stage Glaucoma

NCT04670575

Sponsor

Vance Thompson Vision

Status

Completed

Last Update Posted

May 20, 2024Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Glaucoma
Cataract
Presbyopia

Interventions

Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

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

Jan 1, 2021Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Dec 13, 2020

First Submission Date that Met QC Criteria

Dec 13, 2020

First Posted Date

Dec 17, 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)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vivity		Patients implanted with Vivity or Vivity Toric intraocular lens at the time of cataract surgery.	Procedure: Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL	Procedure	Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL	Vivity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected Distance Visual Acuity		4-6 months
Uncorrected Intermediate Visual Acuity		4-6 months
Uncorrected Near Visual Acuity		4-6 months

Secondary Outcomes

Measure	Description	Time Frame
Contrast Sensitivity	As measured by Pelli Robson Chart	4-6 months
Patient Satisfaction and Spectacle Independence Survey Results		4-6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
Subjects with documented diagnosis of pre-perimetric glaucoma
Calculated lens power within Vivity/Vivity toric range
Willing and able to comprehend informed consent and complete 4-6 month post-op visit
Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion Criteria:

Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
Previous ocular surgery including refractive surgery
Subjects who are pregnant or plan to become pregnant during the course of the study.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian M Shafer, MD	Vance Thompson Vision	Principal Investigator

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
D005901	Glaucoma
D002386	Cataract
D011305	Presbyopia

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002387	Cataract Extraction

Ancestor Terms

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided