Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study
This study, taking place in London, Ontario, is testing two treatments for a rare eye condition called neurotrophic keratitis, which affects eye sensation. The treatments are a surgery called corneal neurotization and special eye drops called Cenergermin. Doctors will choose which treatment is best for each patient, and the study doesn't randomly assign them. Researchers will follow ten adult participants for a year, checking their vision, eye health, and how they feel about their quality of life. The main goal is to see if it's practical to compare these two treatments more widely in the future to help more people with this condition.
At a glance
What is this study about?
This study is about a problem called neurotrophic keratitis (pronounce it: NEW-row-TRO-fik KEH-ruh-TY-tiss). This is a rare eye condition where the nerves in the clear front part of your eye (the cornea) don't work properly. This means you might not feel things in your eye as well, and it can lead to problems like sores or scarring on your cornea, which can affect your vision.
Currently, there are two main ways to treat this condition. One is a surgery called corneal neurotization, where doctors use healthy nerves from another part of your body to help your eye's nerves. The other treatment is Cenergermin (brand name Oxervate), which are eye drops that help your eye heal and nerve cells grow back. This study wants to understand more about how these two treatments compare.
Because neurotrophic keratitis is rare, it's hard to do big studies. This 'pilot' study is a smaller first step. It will help researchers learn if it's possible and practical to run a larger study comparing these treatments directly. The information gathered here will help them plan for the future, hopefully leading to better treatments for people with this eye condition.
Key takeaways
- This study is for a rare eye condition called neurotrophic keratitis to improve understanding of treatments.
- It compares surgery (corneal neurotization) with eye drops (Cenergermin).
- Your doctor will decide your treatment, not the study.
- Participation involves 8 clinic visits over 12 months.
- It's a 'pilot' study to help plan bigger research in the future.
- All tests are standard eye checks and questionnaires.
Who may be eligible?
To be part of this study, you need to be at least 19 years old. You must have neurotrophic keratitis, and your doctor must have identified that your eye sensation is reduced or completely gone. Importantly, your eye doctor must believe that either the corneal neurotization surgery or the Cenergermin eye drops would be a suitable treatment for you.
There are also some reasons why you wouldn't be able to join. These include if you have an active eye infection or inflammation. If you've already had corneal neurotization surgery on the affected eye, you wouldn't be eligible. Also, if there are medical reasons preventing you from having general anaesthesia or surgery, or if you're currently in another medical study that involves trying a new treatment, you wouldn't be able to participate. You also need to be able to understand and agree to take part.
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 19 years old or older?
- Do you have a diagnosis of neurotrophic keratitis with reduced eye sensation?
- Has your eye doctor suggested either the surgery or eye drops as a treatment option for you?
- Do you currently have an active eye infection or inflammation?
- Have you had corneal neurotization surgery on the affected eye before?
- Are you able to provide your consent (agreement) to take part?
What does participation involve?
If you join this study, the treatment you receive, either surgery or eye drops, will be decided by your eye doctor, just like in regular care — it won't be chosen randomly for the study. You will have eight visits to the Ivey Eye Institute over a 12-month period. These visits happen at specific times: before treatment, then 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, and finally 12 months after starting treatment. During these visits, doctors will perform routine eye checks. They will test how sensitive your eye is, take pictures of your eye nerves, look closely at your eye with a special light, check your eye pressure, and test your vision. You'll also be asked to fill out a short questionnaire about how your eye condition affects your daily life. All these checks are standard and won't involve anything extra or uncomfortable for the research. You and your doctor will always know which treatment you are receiving.
Potential risks and benefits
Locations (1)
- Ivey Eye Institute, St. Joseph's Health Care LondonVerified postcodeLondon, Canada
Common questions
What is neurotrophic keratitis?
It's a rare eye condition where the nerves in the clear front part of your eye (the cornea) are damaged, causing reduced feeling and potential vision problems.
What are the treatments being looked at?
The study compares a special surgery called corneal neurotization with eye drops called Cenergermin (Oxervate).
Will I get to choose my treatment?
No, your doctor will decide which treatment is best for you, based on what they usually recommend for your specific condition. You won't be randomly assigned.
How long will I be in the study?
You will be followed for 12 months, with eight visits to the clinic during that time.
What kind of tests will I have?
You'll have regular, non-invasive eye exams like vision tests, checks of your eye's sensitivity, and pictures of your eye nerves, plus a questionnaire about your well-being.
How to find out more
Alex Camacho, MD, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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