CataractNCT07228091
Surgical Procedure Efficiency Evaluation stuDy
An observational study of Cataract and Vitreous Hemorrhage, run by Alcon Research at 1 site in United Kingdom.
Trial summary
The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Vitreous Hemorrhage, Retinal Detachment
- What is being tested?
- UNITY VCS and CONSTELLATION
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subjects will be recruited from the clinical practice of the participating Investigator.
Who may be able to join
- Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.
- Planned combined phacovitrectomy procedure at one of the selected surgical sites.
- Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.
Who cannot join
- Unplanned/emergency phacovitrectomy.
- Pregnant.
- Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Manchester Royal Eye Hospital
Manchester, M13 9WL
About this study
Official title: Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting
The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.
Read the detailed description
Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.
- Conditions
- Cataract, Vitreous Hemorrhage, Retinal Detachment, Macular Pucker, Macular Holes
- Being tested
- UNITY VCS, CONSTELLATION
- Keywords
- anterior segment ophthalmic surgery, posterior segment ophthalmic surgery
- Medical subject headings
- Cataract, Vitreous Hemorrhage, Retinal Detachment, Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNITY VCSDevice
Also called UNITY® Vitreoretinal Cataract System (VCS)
UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).
CONSTELLATIONDevice
Also called CONSTELLATION® Vision System
CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy).
| Study group | Role | What they receive |
|---|---|---|
| UNITY VCS | Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) Receives: Device: UNITY VCS | |
| CONSTELLATION | Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) Receives: Device: CONSTELLATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)?
Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient.
Measured: Up to Day 1 post completion of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start9 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manchester Royal Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Manager, Health Economics/Outcomes Research, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228091
- Sponsor's protocol ID
- CTV678-H003
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting
- ClinicalTrials.gov ID
- NCT07228091
- Acronym / sponsor ID
- CTV678-H003
- Conditions
- Cataract, Vitreous Hemorrhage, Retinal Detachment, Macular Pucker, Macular Holes
- Keywords
- anterior segment ophthalmic surgery, posterior segment ophthalmic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Manchester Royal Eye Hospital
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Nov 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.
The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.
Detailed description
Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITY VCS | – | Device: UNITY VCSSubjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) |
| CONSTELLATION | – | Device: CONSTELLATIONSubjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the clinical practice of the participating Investigator.
Key inclusion criteria (3 listed)
- Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.
- Planned combined phacovitrectomy procedure at one of the selected surgical sites.
- Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.
Key exclusion criteria (4 listed)
- Unplanned/emergency phacovitrectomy.
- Pregnant.
- Past history of phacovitrectomy. cataract, vitrectomy in the planned 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 |
|---|---|---|
| UNITY VCSAlso: UNITY® Vitreoretinal Cataract System (VCS)UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy). | Device | UNITY VCS |
| CONSTELLATIONAlso: CONSTELLATION® Vision SystemCONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy). | Device | CONSTELLATION |
Primary outcome
Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)?
Time frame: Up to Day 1 post completion of the surgery
Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- 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.
Manager, Health Economics/Outcomes Research study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Vitreous Hemorrhage, run by Alcon Research at 1 site in United Kingdom.
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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)? (time frame: Up to Day 1 post completion of the surgery). 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 13 Aug 2026.