Epiretinal MembraneNCT07054281
UNITY VCS Vitreoretinal Surgery
A study testing UNITY Vitreoretinal Cataract System (VCS), CONSTELLATION Vision System and Vitreoretinal ophthalmic surgery in people with Epiretinal Membrane and Macular Hole, run by Alcon Research at 8 sites in United States.
Trial summary
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Hole, Visually Significant Vitreous Floater
- What is being tested?
- UNITY Vitreoretinal Cataract System (VCS), CONSTELLATION Vision System and Vitreoretinal ophthalmic surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 surgery for a clinically documented posterior vitreoretinal medical condition.
- Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety.
- Diagnosis of glaucoma or suspected ocular hypertension.
- Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months).
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Charles Retina Institute
Germantown, Tennessee, 38138
Retina Associates of Orange County
Laguna Hills, California, 92653
NYC Retina - Manhattan
New York, New York, 10003
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
The Eye Institute of Utah
Salt Lake City, Utah, 84107
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
About this study
Official title: UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
Read the detailed description
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
- Conditions
- Epiretinal Membrane, Macular Hole, Visually Significant Vitreous Floater, Vitreomacular Traction, Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
- Being tested
- UNITY Vitreoretinal Cataract System (VCS), CONSTELLATION Vision System, Vitreoretinal ophthalmic surgery
- Keywords
- Vitreoretinal Disease
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNITY Vitreoretinal Cataract System (VCS)Device
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery.
CONSTELLATION Vision SystemDevice
CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.
Vitreoretinal ophthalmic surgeryProcedure or surgery
Ophthalmic surgery performed in the posterior segment of the eye
| Study group | Role | What they receive |
|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) Receives: Device: UNITY Vitreoretinal Cataract System (VCS); Procedure: Vitreoretinal ophthalmic surgery |
| CONSTELLATION Vision System | Active comparator | Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System Receives: Device: CONSTELLATION Vision System; Procedure: Vitreoretinal ophthalmic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vitreoretinal surgeries performed using 27-gauge consumables
The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery
Measured: Day 0 operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Sponsor's business decision based on strategic shifts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054281
- Sponsor's protocol ID
- CTV678-P001
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNITY VCS Vitreoretinal Surgery: Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07054281
- Acronym / sponsor ID
- CTV678-P001
- Conditions
- Epiretinal Membrane, Macular Hole, Visually Significant Vitreous Floater, Vitreomacular Traction, Vitreous Hemorrhage, Proliferative Diabetic Retinopathy
- Keywords
- Vitreoretinal Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's business decision based on strategic shifts
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
Detailed description
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Device: UNITY Vitreoretinal Cataract System (VCS), Procedure: Vitreoretinal ophthalmic surgeryVitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) |
| CONSTELLATION Vision System | Active comparator | Device: CONSTELLATION Vision System, Procedure: Vitreoretinal ophthalmic surgeryVitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requires surgery for a clinically documented posterior vitreoretinal medical condition.
- Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (4 listed)
- Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety.
- Diagnosis of glaucoma or suspected ocular hypertension.
- Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months).
- Other protocol-specified 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 System (VCS)UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery. | Device | UNITY Vitreoretinal Cataract System (VCS) |
| CONSTELLATION Vision SystemCONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. | Device | CONSTELLATION Vision System |
| Vitreoretinal ophthalmic surgeryOphthalmic surgery performed in the posterior segment of the eye | Procedure or surgery | CONSTELLATION Vision System, UNITY Vitreoretinal Cataract System (VCS) |
Primary outcome
Percentage of vitreoretinal surgeries performed using 27-gauge consumables
Time frame: Day 0 operative
The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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, Surgical study director
Alcon Research, LLC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UNITY Vitreoretinal Cataract System (VCS), CONSTELLATION Vision System and Vitreoretinal ophthalmic surgery in people with Epiretinal Membrane and Macular Hole, run by Alcon Research at 8 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of vitreoretinal surgeries performed using 27-gauge consumables (time frame: Day 0 operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.