Vitreoretinal Disease With or Without CataractsNCT06165744

Next Generation Cataract and Vitreoretinal Surgery Study

A study testing UNITY Vitreoretinal Cataract System and Posterior segment surgery in the operating room with or without simultaneous cataract surgery in people with Vitreoretinal Disease With or Without Cataracts, run by Alcon Research at 5 sites in Australia.

Completed

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

Official record

Search all trials

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 formal user feedback. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vitreoretinal Disease With or Without Cataracts
What is being tested?: UNITY Vitreoretinal Cataract System and Posterior segment surgery in the operating room with or without simultaneous cataract surgery
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 5 sitesAustralia
Study dates: 27 Feb 2024to 19 Aug 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
Clear media except for cataract and vitreous hemorrhage;
In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
Other protocol-defined inclusion criteria may apply.

Who cannot join

Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
Neovascular or uncontrolled glaucoma;
Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
Inadequate pupil dilation (less than 6 millimeters);
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Australia5 sites

Adelaide Eye & Retina Centre
Adelaide, South Australia, 5000
NSW Retina Pty Ltd
Hurstville, New South Wales, 2220
Southwest Retina
Liverpool, New South Wales, 2170
Pennington Eye Clinic
North Adelaide, South Australia, 5006
Sydney Retina Clinic & Day Surgery
Sydney, New South Wales, 2000

Other trials in Australia

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 formal user feedback.

Read the detailed description

Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.

Conditions: Vitreoretinal Disease With or Without Cataracts
Being tested: UNITY Vitreoretinal Cataract System, Posterior segment surgery in the operating room with or without simultaneous cataract surgery
Keywords: Vitreoretinal surgery, Vitreoretinal with cataract surgery

What participants receive

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

UNITY Vitreoretinal Cataract SystemDevice
Also called UNITY VCS
UNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery
Posterior segment surgery in the operating room with or without simultaneous cataract surgeryProcedure or surgery
Posterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).

Study groups in NCT06165744
Study group	Role	What they receive
UNITY VCS	Experimental	Posterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS Receives: Device: UNITY Vitreoretinal Cataract System; Procedure: Posterior segment surgery in the operating room with or without simultaneous cataract surgery

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 Using Vitreoretinal or Combined 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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Day 0

Secondary outcomes (3)

Mean Total Time in Eye
The time from first entry into eye/first trocar in to incision closure/last trocar out was measured using a stopwatch and recorded in minutes. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Day 0 operative, up to surgery completion
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"
As reported by the examiner at the Month 3 visit. Intended treatment included macular hole closure, retinal attachment, etc. as applicable for the patient's condition. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Month 3 Postoperative
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3
Visual acuity was assessed with refractive correction in place using a Snellen visual acuity chart. Results were converted to decimal VA, where 2.00 decimal equates to 20/16 Snellen (better than normal distance eyesight), 1.00 decimal equates to 20/20 Snellen (normal distance eyesight), and 0.1 decimal equates to 6/600 Snellen (worse than normal distance eyesight). A positive change value indicates an improvement. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
Measured: Preoperative (Day -30 to 0), Month 3 Postoperative

Timeline

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

27 Feb 202419 Aug 2024

First posted11 Dec 2023
Study start27 Feb 2024
Primary completion23 May 2024
Study completion19 Aug 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.
Other trials for Vitreoretinal Disease With or Without CataractsStudies 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: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06165744
Sponsor's protocol ID: CTV678-E001
Status last verified: Jun 2025
First submitted: 4 Dec 2023
Last updated: 25 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Next Generation Cataract and Vitreoretinal Surgery Study
ClinicalTrials.gov ID: NCT06165744
Acronym / sponsor ID: CTV678-E001
Conditions: Vitreoretinal Disease With or Without Cataracts
Keywords: Vitreoretinal surgery, Vitreoretinal with cataract surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 27 Feb 2024 (actual)
Primary completion: 23 May 2024 (actual)
Study completion: 19 Aug 2024 (actual)
First posted: 11 Dec 2023 (actual)
Results: Posted 25 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 formal user feedback.

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	Device: UNITY Vitreoretinal Cataract System, Procedure: Posterior segment surgery in the operating room with or without simultaneous cataract surgeryPosterior segment surgery in the operating room with or without simultaneous cataract surgery performed with UNITY VCS

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
Clear media except for cataract and vitreous hemorrhage;
In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
Neovascular or uncontrolled glaucoma;
Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
Inadequate pupil dilation (less than 6 millimeters);
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
UNITY Vitreoretinal Cataract SystemAlso: UNITY VCSUNITY Vitreoretinal Cataract System (VCS) with console, remote control, foot controller, UNITY TOTAL PLUS Combined Procedure Pak, and additional devices as needed to complete surgery	Device	UNITY VCS
Posterior segment surgery in the operating room with or without simultaneous cataract surgeryPosterior segment surgery involves removal of the vitreous (i.e., vitrectomy) followed by additional interventions as needed. Cataract surgery involves removal of the crystalline lens (which is often cloudy).	Procedure or surgery	UNITY VCS

Primary outcome

Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined 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 the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.

3 secondary outcomes

Mean Total Time in Eye
Time frame: Day 0 operative, up to surgery completion
Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"
Time frame: Month 3 Postoperative
Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3
Time frame: Preoperative (Day -30 to 0), Month 3 Postoperative

Results and safety

Results posted to the registry on 25 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	118	117

Primary outcome: Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined 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 = 117
Value	100 (96.9 to 100)

Population analysed: Full Analysis Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	1 of 118 (0.8%)	0 of 118 (0%)	0 of 118
UNITY VCS Ocular - Study Eye	38 of 118 (32.2%)	21 of 118 (17.8%)	0 of 118
UNITY VCS Systemic	6 of 118 (5.1%)	1 of 118 (0.8%)	0 of 118

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Sr. Clinical Operations Lead, Surgical study director

Alcon Research, LLC

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

Questions about this trial

What is this clinical trial studying?

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 4 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 25 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 5 sites in Australia. 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 25 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 Using Vitreoretinal or Combined 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 NCT06165744.

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 25 Jun 2025.