Comparing surgery times for UNITY® VCS and CONSTELLATION® Vision System
Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting
Alcon Research · NCT07228091
This study will see if the UNITY® VCS or the CONSTELLATION® Vision System leads to shorter combined cataract and vitrectomy (phacovitrectomy) surgery times for adults planned for 25‑gauge procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research (industry) |
| Locations | 1 site (Manchester) |
| Trial ID | NCT07228091 on ClinicalTrials.gov |
What this trial studies
This is a single-visit, real-world time-and-motion study conducted in the United Kingdom to compare surgical procedure times between the UNITY® VCS and the CONSTELLATION® Vision System during routine combined anterior–posterior segment (phacovitrectomy) operations. Eligible patients are adults scheduled for planned combined phacoemulsification and 25‑gauge vitrectomy at participating surgical sites, and procedures are observed and timed under normal operating conditions. Emergency or unplanned surgeries, pregnant patients, and eyes with prior phacovitrectomy are excluded. The study is sponsored by Alcon Research in collaboration with Manchester Royal Eye Hospital and focuses on workflow and efficiency rather than clinical outcomes.
Who should consider this trial
Good fit: Adults who can consent and are scheduled for a planned combined phacoemulsification and 25‑gauge vitrectomy (phacovitrectomy) at a participating UK surgical site are ideal candidates.
Not a fit: Patients requiring emergency or unplanned phacovitrectomy, those who are pregnant, or those with prior phacovitrectomy in the planned operative eye are excluded and will not benefit from participation.
Why it matters
Potential benefit: If successful, the results could help surgeons choose the system that shortens operating time and improves surgical efficiency, which may reduce anesthesia exposure and operating room costs.
How similar studies have performed: Device-comparison and time-and-motion studies have measured surgical workflow for vitrectomy systems before, but direct real-world comparisons between these two specific systems for combined phacovitrectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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: * Unplanned/emergency phacovitrectomy. * Pregnant. * Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye. * Other protocol-defined exclusion criteria may apply.
Where this trial is running
Manchester
- Manchester Royal Eye Hospital — Manchester, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cataract, Vitreous Hemorrhage, Retinal Detachment, Macular Pucker, Macular Holes, anterior segment ophthalmic surgery, posterior segment ophthalmic surgery