CataractNCT06071104

Next Generation Cataract Surgery Study

A study testing Anterior segment ophthalmic surgery and UNITY VCS in people with Cataract, run by Alcon Research at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Cataract
What is being tested?: Anterior segment ophthalmic surgery and UNITY VCS
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 4 sitesUnited States
Study dates: 6 Dec 2023to 28 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to understand and sign an IRB/IEC approved Informed Consent form.
Willing and able to attend all scheduled visits as required by the protocol.
Clinically documented diagnosis of age-related noncomplicated cataract.
Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Women of childbearing potential as defined in the protocol.
Planned postoperative procedures during the course of the study in the operative eye.
Previous intraocular or corneal surgery in the operative eye.
Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative eye.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center
San Diego, California, 92122
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Miramar Eye Specialists Medical Group
Ventura, California, 93003
Wolfe Eye Clinic
West Des Moines, Iowa, 50266

Other trials in United States

About this study

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.

Read the detailed description

Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.

Conditions: Cataract
Being tested: Anterior segment ophthalmic surgery, UNITY VCS
Keywords: Anterior segment ophthalmic surgery
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anterior segment ophthalmic surgeryProcedure or surgery
Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)
UNITY VCSDevice
UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit

Study groups in NCT06071104
Study group	Role	What they receive
UNITY VCS	Experimental	Anterior segment ophthalmic surgery performed with UNITY VCS Receives: Procedure: Anterior segment ophthalmic surgery; Device: UNITY VCS

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"
As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Day 0

Secondary outcomes (1)

Time From Incision Entry to Incision Closure
The time from incision entry to incision closure was measured using a stopwatch and recorded in seconds. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Day 0 surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 202328 Jun 2024

First posted6 Oct 2023
Study start6 Dec 2023
Primary completion23 May 2024
Study completion28 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06071104
Sponsor's protocol ID: CTV678-E002
Status last verified: May 2025
First submitted: 2 Oct 2023
Last updated: 4 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Berdahl J, Terveen D, Aboughaida A, Dyk DW, Yalamanchili S, Makari S, Thompson V. Bench Evaluation of Intraocular Pressure Control with Clinical Assessment of Anterior Chamber Stability of a Dual Peristaltic Phacoemulsification Device. Clin Ophthalmol. 2026 Feb 11;20:570189. doi: 10.2147/OPTH.S570189. eCollection 2026.
PubMed 41710169

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Next Generation Cataract Surgery Study
ClinicalTrials.gov ID: NCT06071104
Acronym / sponsor ID: CTV678-E002
Conditions: Cataract
Keywords: Anterior segment ophthalmic surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 6 Dec 2023 (actual)
Primary completion: 23 May 2024 (actual)
Study completion: 28 Jun 2024 (actual)
First posted: 6 Oct 2023 (actual)
Results: Posted 4 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
UNITY VCS	Experimental	Procedure: Anterior segment ophthalmic surgery, Device: UNITY VCSAnterior segment ophthalmic surgery performed with UNITY VCS

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Able to understand and sign an IRB/IEC approved Informed Consent form.
Willing and able to attend all scheduled visits as required by the protocol.
Clinically documented diagnosis of age-related noncomplicated cataract.
Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Women of childbearing potential as defined in the protocol.
Planned postoperative procedures during the course of the study in the operative eye.
Previous intraocular or corneal surgery in the operative eye.
Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative eye.
Other protocol-defined exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anterior segment ophthalmic surgeryCataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification)	Procedure or surgery	UNITY VCS
UNITY VCSUNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY Cataract FMS Pack, and UNITY Anterior Vitrectomy Kit	Device	UNITY VCS

Primary outcome

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"
Time frame: Day 0
As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

1 secondary outcome

Time From Incision Entry to Incision Closure
Time frame: Day 0 surgery

Results and safety

Results posted to the registry on 4 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UNITY VCS	108	107

Primary outcome: Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"

Time frame: Day 0. Number (95% Confidence Interval). Unit: percentage of responses

Measure	UNITY VCS n = 107
Value	99.1 (94.9 to 100.0)

Population analysed: All Implanted Analysis Set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 108 (0%)	0 of 108 (0%)	0 of 108
UNITYVCSstudyeye	2 of 108 (1.9%)	0 of 108 (0%)	0 of 108
UNITYVCSSystemic	3 of 108 (2.8%)	0 of 108 (0%)	0 of 108

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41710169Berdahl J, Terveen D, Aboughaida A, Dyk DW, Yalamanchili S, Makari S, Thompson V. Bench Evaluation of Intraocular Pressure Control with Clinical Assessment of Anterior Chamber Stability of a Dual Peristaltic Phacoemulsification Device. Clin Ophthalmol. 2026 Feb 11;20:570189. doi: 10.2147/OPTH.S570189. eCollection 2026.
Individual participant dataSharing planned: No

Related trials for Cataract

Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
Recruiting
Trial Comparing miLOOP Device Assisted Phacoemulsification vs Standard Surgery for Dense Cataracts: Effects on Endothelial Cell Loss, Energy Use, and Vision Recovery
Cataract, Endothelial Cell Density
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Lead, CRD Surgical study chair

Alcon Research, LLC

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anterior segment ophthalmic surgery and UNITY VCS in people with Cataract, run by Alcon Research at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?" (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06071104, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.