Observational Study to Investigate the Short-term Effects of Transcorneal Electrical Stimulation on Visual Performance
This study is for people with conditions like Retinitis Pigmentosa, Usher Syndrome, or Cone Rod Dystrophy who are already using a special eye treatment called Transcorneal Electrical Stimulation (TES) with the OkuStim System. Many people using this treatment notice their vision feels better for a short time afterwards. This research wants to find out if these short-term improvements they feel can actually be seen and measured with eye tests. The study involves answering questions and having a series of eye checks before and after a TES treatment session. The goal is to understand more about how TES works and if the benefits people report can be scientifically proven.
At a glance
What is this study about?
You might have heard of conditions like Retinitis Pigmentosa (RP), Usher Syndrome, or Cone Rod Dystrophy. These are eye conditions that can slowly cause you to lose your eyesight over time. A treatment called Transcorneal Electrical Stimulation (TES) uses a special system called OkuStim. In Europe, this treatment is approved to help slow down how quickly vision loss happens.
Some people who use the OkuStim system say that their vision seems to get a bit better for a short time after their treatment. However, doctors haven't thoroughly studied these short-term improvements yet. This research aims to look into these reported benefits. The main goal is to check if these temporary improvements people feel can be measured using different eye tests, rather than just relying on what people tell us.
By taking part, you would help scientists understand more about how the OkuStim TES treatment works and whether the short-term benefits people report can be seen on standard eye tests. This knowledge could be really helpful for better understanding and improving care for people living with these eye conditions.
Key takeaways
- Study explores short-term vision changes after OkuStim TES treatment.
- Aims to objectively measure subjective improvements reported by patients.
- For adults already using OkuStim for Retinitis Pigmentosa or similar conditions.
- Involves eye tests before and after a standard TES treatment session.
- Participation helps scientists understand how TES works better.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with Retinitis Pigmentosa or similar conditions like Usher Syndrome or Cone Rod Dystrophy.
You must already be using the OkuStim system for your treatment and feel that you experience short-term improvements in your vision after each session. You also need to be able to understand the study information and agree to take part.
However, you won't be able to join if you have other serious eye conditions, if you're taking part in another clinical study that might affect the results, or if you have any serious health problems that could make taking part unsafe for you.
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?
- Have you been diagnosed with Retinitis Pigmentosa, Usher Syndrome, or Cone Rod Dystrophy?
- Are you currently using the OkuStim System for your treatment?
- Do you feel that your vision temporarily improves after your TES treatment?
- Are you able to understand the study information and give your consent?
What does participation involve?
If you decide to take part, you'll first answer some questions about your experiences with the OkuStim treatment and how your vision changes afterwards. Then, you'll have a number of eye tests, including checks for your sight, how well you see contrasts, and your field of vision.
After these initial tests, you'll have a 30-minute TES treatment session using your OkuStim system, just like you normally would. Immediately after this, some of your eye tests (sight and contrast) will be repeated. You'll then have a break of about three and a half hours, after which you'll answer more questions about how you feel your vision is. Finally, you'll have another set of eye tests, including your full sight, contrast, and field of vision checks again. The entire process will take place over one day.
Potential risks and benefits
Locations (1)
- Augenzentrum Frankfurt Prof. Koch GmbHVerified postcodeFrankfurt am Main, Germany· Recruiting
Common questions
What is Retinitis Pigmentosa?
It's a group of eye conditions that cause damage to the retina at the back of your eye, leading to gradual loss of vision.
What is the OkuStim System?
It's a medical device used for Transcorneal Electrical Stimulation (TES), a treatment approved in the EU to slow down the progression of certain eye diseases.
Do I have to stop my current treatment to join?
No, you must already be using the OkuStim System for your treatment to be eligible for this study.
Will I get paid to take part?
The information provided does not state if participants will be compensated. You should ask the study team about this.
How long will my involvement in the study last?
Your participation will involve a single visit lasting a full day, including tests and your usual TES treatment.
How to find out more
Claudia Büdel
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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