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Enrolling by invitationOBSERVATIONAL

5 Year Follow up of SMILE® Procedure for the Correction of Hyperopia

This study is a five-year follow-up for people who had SMILE® pro eye surgery to correct long-sightedness (hyperopia), which sometimes included astigmatism. Researchers want to see how stable their vision has been, how predictably the surgery worked, and how safe it has been over the long term. This information is really important because it helps improve how doctors perform the surgery and choose who it's best for in the future. About 100 patients in Germany and the Czech Republic will take part. They will have one easy, pain-free check-up, just like their last visit five years ago. This helps gather valuable information about the lasting effects of the procedure.

At a glance

Status
Enrolling by invitation
Sponsor
Gemini Eye Clinic
Enrolment target
100
Start
01 Jan 2025
Estimated completion
31 Dec 2025

What is this study about?

Imagine you had a special eye operation called SMILE® pro five years ago to help you see things far away more clearly (this is called hyperopia, or long-sightedness). This study is like a five-year check-up for that operation. Doctors want to see how well your vision has stayed steady and clear since then.

They are interested in a few key things: how predictable the results were (did your vision turn out as expected?), how stable your vision has been over time (has it remained good, or changed?), and how safe the procedure has proven to be in the long run. By understanding these long-term effects, they can make sure the operation is even better and safer for people in the future.

This valuable information will help improve the way doctors decide who the SMILE® pro procedure is best for and how they perform it. It's all about making sure operations like this give the best possible results for patients both now and many years down the line.

Key takeaways

  • This study checks the long-term results of SMILE® pro eye surgery for long-sightedness.
  • It's a five-year follow-up for people who had the surgery in a previous study.
  • Researchers want to understand how stable, predictable, and safe the procedure has been.
  • Findings will help improve future eye surgery treatments for others.
  • Participation involves one simple, pain-free eye check-up.
  • The study has been reviewed and approved by an ethics committee.

Who may be eligible?

This study is only for people who previously had SMILE® pro eye surgery for long-sightedness as part of an earlier research study called PHOBOS. You also need to be able to understand what the study involves and be happy to sign a consent form, which shows you agree to take part.

It's important that you are able to attend the visit and follow the study instructions, as this helps the researchers gather accurate information.

You won't be able to join if you have serious eye problems or other health conditions that would make it difficult for you to complete the visit. Also, if you didn't have the SMILE® pro surgery as part of the specific PHOBOS study, you won't be eligible.

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.

  1. Did you have SMILE® pro surgery for long-sightedness?
  2. Was your surgery part of the 'PHOBOS' research study?
  3. Can you understand information about the study and sign a consent form?
  4. Are you able to attend a single clinic visit for eye tests?
Answer every question to see your result.

What does participation involve?

If you are invited and choose to take part in this study, you would have just one visit to the clinic. During this visit, you would have a series of standard eye tests. These tests are not painful and are similar to the eye checks you might have had five years ago as part of the original study. The doctors would be checking your vision and the health of your eyes, just as they did before. There will be no medication and no further follow-up after this single visit.

Potential risks and benefits

The main benefit of taking part is contributing to important medical research that will help improve eye surgery for future patients. There are no direct medical benefits to you, as this is a follow-up assessment. The tests involved are standard, non-invasive eye examinations and are considered very low risk, similar to a regular eye check-up. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

  • Gemini Eye Clinic
    Verified postcode
    Zlín, Czechia
  • Universitätsklinikum Marburg - Klinik für Augenheilkunde
    Verified postcode
    Marburg, Germany

Common questions

What is hyperopia?

Hyperopia is the medical term for long-sightedness, meaning you can see distant objects more clearly than those up close.

What is SMILE® pro surgery?

SMILE® pro is a type of laser eye surgery used to correct vision problems like long-sightedness or short-sightedness.

Do I have to do anything special before my visit?

No, you don't need to do anything special. Just come ready for your eye check-up.

Will I get paid to participate?

The information provided does not mention any payment for participation in this study.

How long will the single visit take?

The information provided does not specify the exact duration of the visit, but it will involve standard eye examinations.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "5 Year Follow up of SMILE® Procedure for the Correction of H…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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