Surgical Procedure Efficiency Evaluation stuDy
This study is called the "Surgical Procedure Efficiency Evaluation" and it's looking at how quickly eye surgeons can complete certain operations using two different types of advanced equipment: the UNITY VCS and the CONSTELLATION Vision System. It's focused on people in the UK who are having a specific type of eye surgery called phacovitrectomy. This operation combines removing a cloudy natural lens (cataract surgery) with a procedure to fix problems at the back of the eye, like bleeding or a detached retina. Researchers want to see if one system helps operations run more smoothly or quickly. The study is conducted by Alcon Vision LLC and aims to gather real-world information on these surgical tools. It's not testing new treatments, but rather comparing existing surgical methods.
At a glance
What is this study about?
Imagine you're having an eye operation, and your surgeon uses special equipment to help them see and work inside your eye. This study is all about comparing two different pieces of this equipment – called UNITY VCS and CONSTELLATION Vision System – to see how efficiently they work during surgery. It's like comparing two different tools to see if one helps a task get done more smoothly or in less time.
The specific operation they're looking at is called a "phacovitrectomy." This is often done when someone has a cloudy lens (a cataract) AND a problem deeper inside the eye, like bleeding (vitreous hemorrhage), a detached retina (where the light-sensitive layer at the back of the eye pulls away), or issues with the very centre of your vision (macular pucker or macular holes). Instead of having two separate operations, these can sometimes be done at the same time.
The main goal is to simply measure and compare the actual time it takes for surgeons to complete these operations using each system. It's important to understand that this study is not about testing new medicines or surgical approaches. Instead, it's about learning more about the tools surgeons already use to help them perform these important eye procedures. The information gathered could help improve future surgical processes.
Key takeaways
- Compares two types of surgical equipment (UNITY VCS and CONSTELLATION) for eye operations.
- Focuses on measuring how long a specific combined eye surgery (phacovitrectomy) takes.
- Not testing new treatments; it observes existing surgical practice.
- For adults in the UK having planned phacovitrectomy surgery.
- Participation involves no extra procedures or hospital visits beyond your planned care.
- Aims to improve surgical efficiency for future patients.
Who may be eligible?
To join this study, you need to understand what the study involves and sign a form confirming you agree to take part. You must be planning to have a specific type of eye surgery called a phacovitrectomy, which combines cataract surgery with another procedure for the back of your eye. This surgery also needs to be planned using specific small surgical tools, known as 25-gauge tools.
There are certain reasons why you wouldn't be able to join. For example, if your surgery is an emergency rather than a planned one, you wouldn't be eligible. Also, if you are pregnant, or if you have had a phacovitrectomy, cataract surgery, or another vitrectomy procedure in the eye needing treatment before, you would not be able to participate. The study is for adults, aged 18 and over.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you understand what the study involves and are you willing to give your permission to participate?
- Are you scheduled for an eye operation that combines cataract removal and treatment for the back of your eye (phacovitrectomy)?
- Is your phacovitrectomy surgery planned, not an emergency?
- Have you not had a phacovitrectomy, cataract, or vitrectomy in the eye needing treatment before?
- Are you not currently pregnant?
What does participation involve?
If you are eligible and agree to take part, your involvement in this study will be quite straightforward. It's a "single visit" study, meaning you won't need extra appointments beyond your planned surgery. During your routine combined eye surgery, researchers will simply observe and record the time it takes for specific steps of the operation using either the UNITY VCS or CONSTELLATION system. You won't receive different medications or have any extra procedures. Your treatment will be exactly as your doctor has planned. The study is purely an observation of the surgical times, so it won't add any extra time to your overall recovery or follow-up from your surgery.
Potential risks and benefits
Locations (1)
- Manchester Royal Eye HospitalVerified postcodeManchester, United Kingdom· Recruiting
Common questions
What is a phacovitrectomy?
It's an eye operation that combines removing a cloudy lens (cataract surgery) with a procedure to fix problems at the back of your eye, like bleeding or a detached retina.
Will my treatment be different if I join the study?
No, your treatment will be exactly the same as your doctor has planned. The study just observes how long existing procedures take with different equipment.
Who is running this study?
The study is being conducted by Alcon Vision LLC, a company that makes eye care products and surgical equipment.
Will I have to come for extra hospital visits?
No, this is a 'single visit' study, meaning your participation happens during your planned surgery and doesn't require extra appointments.
Why is this study important?
By comparing how quickly operations are done with different tools, the study aims to find ways to make eye surgeries more efficient in the future, potentially benefiting other patients.
How to find out more
Alcon Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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