UNITY VCS for Vitreoretinal Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two eye surgery systems to determine which is more effective and safer for treating vitreoretinal disorders. These disorders affect the back part of the eye and may require surgery to improve vision. Participants will undergo vitreoretinal ophthalmic surgery with either the UNITY VCS or the CONSTELLATION system. Individuals with a diagnosed vitreoretinal condition who need surgery may be suitable candidates for this trial. As an unphased trial, it provides a unique opportunity to advance surgical options for vitreoretinal disorders.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these eye surgery systems are safe for treating vitreoretinal disorders?
Research has shown that the UNITY Vitreoretinal Cataract System (VCS) is already approved for surgery, indicating it has met safety standards for similar operations. However, specific safety data from past studies on UNITY VCS remains limited.
This trial uses the CONSTELLATION Vision System for comparison. As a well-known system currently used in eye surgeries, its continued use suggests a strong safety record.
In summary, both the UNITY VCS and CONSTELLATION are designed for eye surgeries and have been used safely in similar situations. Although detailed safety data for UNITY VCS is limited, its approval and the established use of CONSTELLATION suggest both systems are likely safe for surgical use.12345Why are researchers excited about this trial?
Researchers are excited about the UNITY Vitreoretinal Cataract System (VCS) because it introduces a novel approach to vitreoretinal ophthalmic surgery by potentially enhancing precision and safety compared to traditional methods like the CONSTELLATION Vision System. This new system is being explored for its ability to integrate advanced technology, which might offer improved surgical outcomes and recovery times for patients with vitreoretinal disorders. The hope is that UNITY VCS could lead to breakthroughs in how these surgeries are performed, providing better vision restoration and patient satisfaction.
What evidence suggests that this trial's eye surgery systems could be effective for vitreoretinal disorders?
Research has shown that the UNITY Vitreoretinal Cataract System (VCS), one of the systems studied in this trial, makes eye surgeries more efficient. Studies found that UNITY VCS improves workflow by 16% compared to other systems like CONSTELLATION, the comparator in this trial. Specifically, setup time decreased by 33% and cleanup time by 38%. These improvements can streamline surgeries and may lead to better patient outcomes. While the focus is on efficiency, findings suggest that UNITY VCS might also be reliable for treating eye disorders.23456
Who Is on the Research Team?
Clinical Trial Lead, Surgical
Principal Investigator
Alcon Research, LLC
Are You a Good Fit for This Trial?
This trial is for adults needing surgery for vitreoretinal conditions like retinal detachment, macular holes, or diabetic retinopathy. Participants should have clear ocular media except for vitreous hemorrhage and floaters. Those with glaucoma, recent eye surgeries (except cataracts), or diseases affecting study safety/results can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo vitreoretinal ophthalmic surgery in one eye using either the UNITY VCS or CONSTELLATION system
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Vitreoretinal ophthalmic surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California