Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
This study focuses on Age-related Macular Degeneration (AMD), an eye condition that affects eyesight. While treatments exist for advanced AMD, there aren't many good ways to measure progress or test new treatments in the earlier stages. This research aims to prove if a specific eye test, called fundus-tracked dark adaptometry, can be a reliable tool for future studies. This test looks at how well your eyes adjust to changes in light. We're testing this on healthy volunteers and people with early or intermediate AMD to understand how it works, how accurate it is, and if it can predict changes over time. The goal is to help scientists develop better ways to find effective treatments for AMD early on.
At a glance
What is this study about?
This study is all about Age-related Macular Degeneration, often called AMD, which is a common eye condition that can affect your central vision. Currently, doctors have good treatments for the very advanced stages of AMD. However, for people in the earlier or middle stages, it's harder to tell if a new treatment is working because we don't have many precise ways to measure small changes in vision.
That's where this study comes in. Researchers are investigating a special eye test called 'fundus-tracked dark adaptometry.' This test looks at how quickly and well your eyes adjust when going from a bright place to a dark place. Think about walking into a dark cinema – your eyes need time to get used to it. This study wants to see if this dark adaptation test can accurately show small changes in vision for people with early and intermediate AMD. If it can, it would be a huge step forward for future studies trying out new treatments.
To do this, the research will involve healthy volunteers to understand how the test works normally. They will also include people with early or intermediate AMD to see how the test picks up on changes related to their condition. The aim is to make sure this test is reliable and sensitive enough to be used in future clinical trials, helping doctors find new and effective ways to treat AMD earlier.
Key takeaways
- This study investigates new ways to measure AMD progression earlier.
- It tests a special eye exam called 'dark adaptometry'.
- No new treatments are given; it's an observational study.
- It includes healthy volunteers and people with early/intermediate AMD.
- Participation involves 2 or 3 visits over several months.
- The goal is to help find better treatments for AMD in the future.
Who may be eligible?
To join this study, you need to be at least 18 years old if you're a healthy volunteer, or at least 55 years old if you have AMD. You also need to be able to understand information in German or English.
If you have early AMD, you would have specific small or medium-sized yellow spots in your eye called drusen, but no changes to your eye's pigment. If you have intermediate AMD, you would have larger drusen and/or changes to your eye's pigment.
You would not be able to join if you have certain conditions like severe claustrophobia, a known pregnancy, or certain eye surgeries in the past (other than cataract surgery, for example). Also, if you have other eye conditions that could affect your vision tests or medical conditions that would make it hard to complete the study, you might not be suitable.
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 or older (healthy) or 55 or older (AMD)?
- Can you understand German or English well enough for study instructions?
- Do you have early or intermediate AMD (if applicable)?
- Are you able to attend appointments at the study site for up to 18 months?
- Have you not had any major eye surgery (other than cataracts) in the eye being studied?
What does participation involve?
If you take part as a healthy volunteer, you would have two visits to the study clinic: one at the start of the study and another about two months later. If you have early or intermediate AMD, you would have three visits: one at the start, another around two months later, and a final visit about 18 months after the start. Each visit will involve various eye tests, including the dark adaptometry test. You might also have imaging scans of your eye, and some blood tests to look for specific markers or genetic information. No medication is given as part of this study; it's purely to observe and test the eye screening methods.
Potential risks and benefits
Locations (1)
- Department of Ophthalmology, University Hospital BonnVerified postcodeBonn, Germany· Recruiting
Common questions
What is AMD?
AMD stands for Age-related Macular Degeneration. It's an eye condition that affects the macula, the part of your eye responsible for sharp, central vision.
What is 'dark adaptometry'?
It's an eye test that measures how well and quickly your eyes adjust to seeing in the dark after being in bright light.
Will I get any treatment in this study?
No, this is an observational study. You won't receive any new treatments; the study is focused on testing new assessment methods.
How long will the study last for me?
If you're a healthy volunteer, you'll have two visits over two months. If you have AMD, you'll have three visits over about 18 months.
Will I need to travel?
This study takes place at one specific location (monocentric), so you would need to travel to that site for your appointments.
How to find out more
Maximilian Pfau, MD, FEBO
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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