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RecruitingNAINTERVENTIONAL

Risk Factors and Progression of Keratoconus

This study, taking place in France, aims to understand more about keratoconus, an eye condition where the cornea thins and bulges, causing blurry vision. Researchers will follow 200 people aged 10 to 40 for two years. Some participants will have eye treatments, like cross-linking surgery or getting special rings placed in their eye, while others will not have these treatments. The researchers want to see how the condition progresses naturally, how well different treatments work, and how changes in the eye are linked to changes in vision. They will collect information about the eyes and even test tears to learn more about the condition. This information could help improve future care for people with keratoconus.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Montpellier
Enrolment target
200
Start
05 Jun 2023
Estimated completion
01 May 2028

What is this study about?

This study is designed to help us learn more about keratoconus, an eye condition that affects many people. When you have keratoconus, the clear front part of your eye, called the cornea, thins and bulges outwards like a cone. This can cause your vision to become blurry and distorted.

The main goal of this research is to closely observe and understand how keratoconus changes over a two-year period in 200 people. Some participants will receive standard treatments for keratoconus, such as cross-linking surgery (which helps strengthen the cornea) or having special rings placed inside the eye (to reshape it). Other participants will not have these specific treatments during the study period. By comparing these groups, doctors hope to gain a clearer picture of how the condition progresses and how different approaches might affect it.

Researchers will collect detailed information about participants' eyes, including how their vision changes and what the cornea looks like. They will also look at tiny proteins found in tears, as these might give clues about the condition. Understanding these links could help doctors in the future predict how keratoconus will develop and choose the best treatments for each person.

Key takeaways

  • Learn about keratoconus progression over two years.
  • Compares current treatments (cross-linking, rings) with no specific intervention.
  • Includes participants aged 10-40 in France.
  • Will collect detailed eye information, including tear analysis.
  • Helps doctors better understand and treat keratoconus in the future.

Who may be eligible?

To take part in this study, you would need to be between 10 and 40 years old. You also need to have keratoconus, whether it's clearly visible and affecting your vision, or if it's in an earlier stage where changes are just starting to show on eye scans, even if your vision is still good.

You should be receiving care for your eyes at one of three specific hospitals in France: CHU Montpellier, CHU Bordeaux, or CHU Toulouse. If you're an adult, you'll need to give your written permission to join after considering it carefully. If you're under 18, one of your parents or legal guardians must give their permission, and you'll also be asked to agree after thinking about it.

There are also a few reasons you might not be able to join. For example, if you're under legal guardianship, have had a corneal implant in both eyes before, or if you plan to move away before the initial part of the study is finished.

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. Are you between 10 and 40 years old?
  2. Do you have keratoconus (diagnosed or suspected)?
  3. Are you receiving eye care at CHU Montpellier, Bordeaux, or Toulouse?
  4. Are you able to provide consent (or a parent/guardian for minors)?
  5. Are you not planning to move before your initial treatment stage finishes?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for up to two and a half years. The visits and what happens during them will depend on whether you have surgery (like cross-linking or an intra corneal ring) or not.

If you don't have surgery, you'll have visits at 6 months, 12 months, and 24 months after starting the study. During these visits, doctors will check your eyes and vision. You'll also be advised not to rub your eyes, as this can worsen keratoconus.

If you do have surgery, your visits will be more frequent at the start: after 7 days, then at 1 month, 6 months, 12 months, and 24 months after your operation. At these appointments, doctors will closely monitor your recovery and how your eye is healing. This study only observes; no extra treatments outside of what your doctor would normally recommend will be given.

Potential risks and benefits

Taking part in this study may offer several potential benefits, such as contributing valuable knowledge that could help future patients with keratoconus. You'll also receive careful monitoring of your eye condition by specialists. As this is an observational study, no new or untested treatments will be given. However, any existing treatments, procedures, or eye drop regimens you are already on carry their own normal risks, which your doctor would discuss with you. You are free to withdraw from the study at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (1)

  • CHU Gui de Chauliac - Service d'Ophtamologie
    Verified postcode
    Montpellier, France· Recruiting

Common questions

What is keratoconus?

Keratoconus is an eye condition where your cornea, the clear front part of your eye, thins and bulges outwards, causing blurry and distorted vision.

How long will the study last?

The study will last for up to two and a half years, depending on your treatment pathway.

Will I receive any new treatments in this study?

No, this study only observes the common treatments and progression of keratoconus. You will not receive any new or experimental treatments.

Can I leave the study at any time?

Yes, you can decide to leave the study at any point without needing to give a reason, and it won't affect your regular medical care.

Who is funding this study?

The information provided does not specify who is funding the study.

How to find out more

Vincent DAIEN, PR

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 "Risk Factors and Progression of Keratoconus…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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