Effective Phaco Time and Endothelial Cell Loss When Using... | NCT07176416

Studies
Effective Phaco Time and Endothelial Cell Loss When Using Veritas

NCT07176416

Sponsor

Aloha Vision Consultants

Status

Recruiting

Last Update Posted

Oct 9, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cataract

Interventions

Veritas Vision System

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

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2025Actual

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Sep 9, 2025

First Submission Date that Met QC Criteria

Sep 9, 2025

First Posted Date

Sep 16, 2025Actual

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

Oct 7, 2025

Last Update Posted Date

Oct 9, 2025Actual

Name	Class
Sengi	INDUSTRY

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a single center, prospective study of cumulative dissipated energy and endothelial cells loss per phacoemulsification procedure after successful cataract surgery. Subjects will be assessed 3 months postoperatively at a single visit. Clinical evaluations will include central corneal thickness, specular microscopy, as well as measurement of visual acuities at distance.

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

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Veritas Vision System	Device	Veritas Vision System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effective phaco time per phacoemulsification procedure		Surgery (Day 0)

Secondary Outcomes

Measure	Description	Time Frame
Endothelial cell loss		1 monthspostoperatively
Total case time	total case time per procedure	Surgery (Day 0)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing age-related cataract surgery.
Planned use of the Catalys Precision Laser System.
Planned implantation of TECNIS intraocular lenses (IOLs).

Exclusion Criteria:

• Moderate-severe any disease state (deemed by the surgeon) that could increase risk of complicated cataract surgery (ie, pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, and prior refractive surgery).

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

Eligible test subjects will be adults who are candidates for age-related cataract surgery with IOL implantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alana K Dunn	Contact	808-688-6898		avc.alanad@gmail.com

Overall Officials

Name	Affiliation	Role
Carlton Yuen, MD	Aloha Vision Consultants	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aloha Vision Consultants	Recruiting	‘Aiea	Hawaii	96701	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

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases