Establishing Fully-Automated Fundus-Controlled Dark Adaptometry: A Validation and Retest-Reliability Study.
Jeannine M Oertli, Kristina Pfau, Hendrik P N Scholl...
https://pubmed.ncbi.nlm.nih.gov/38112496Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID07515521
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Led by Maximilian Pfau · Updated on 2026-04-07
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating age-related macular degeneration (AMD), a common cause of vision loss, focusing on early and intermediate stages where effective treatments and validated functional tests are lacking. This observational study aims to validate a special vision test called fundus-tracked dark adaptometry to assess how well it measures changes in eye function and predicts disease progression. The study also explores links between dark adaptation and retinal imaging, blood markers, metabolism, proteins, and genetics related to AMD. Participants are grouped into healthy volunteers, early AMD, and intermediate AMD categories. Healthy volunteers attend 2 visits at baseline and 2 months, while those with early or intermediate AMD attend 3 visits at baseline, 2 months, and 18 months. The study involves detailed eye testing using dark adaptometry and imaging, along with blood sample analysis to examine biomarkers and genetic factors. During the study, participants undergo vision tests that measure rod-mediated dark adaptation, particularly the Rod-Intercept Time at 18 months, which is the main outcome. Researchers also assess test reliability and changes over time. Study visits include retinal imaging and blood tests to evaluate biomarkers and genetics. Participants must be able to understand German or English and comply with procedures, with safety monitored throughout the study period ending in December 2028.
CONDITIONS
Brief Title
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Written informed consent
- All biological sexes and gender identities
- Age 18 years or older for healthy volunteers; 55 years or older for participants with AMD
- Ability to understand German or English sufficiently for study information and procedures
- Healthy Volunteers: No drusen larger than 63 micrometers and no subretinal drusenoid deposits in either eye
- Early AMD: Study eye with drusen larger than 63 micrometers but less than 125 micrometers and no pigmentary changes
- Intermediate AMD: Study eye with drusen larger than 125 micrometers and/or pigmentary changes
You will not qualify if you...
- Claustrophobia relevant to dark-adaptation procedures
- Hypersensitivity to indocyanine green or sodium iodide, iodine allergy, or hyperthyroidism
- Known pregnancy
- Study eye history of ocular surgery other than cataract surgery, YAG capsulotomy, or laser retinopexy
- Ocular disease in the study eye that could affect visual function testing as judged by investigators
- Medical conditions or planned operations that could interfere with follow-up
- Inability to comply with study procedures or insufficient language skills
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 18 months
Participants undergo vision and imaging tests including fundus-tracked dark adaptometry, multimodal retinal imaging, and assessments of blood-based biomarkers, metabolomics, proteomics, and genetic variants to evaluate early and intermediate AMD.
2 to 3 visits depending on group assignment
Long-term Monitoring
Duration - Up to 18 months
Participants are monitored over time to assess changes in vision related to AMD using repeated tests and imaging.
Follow-up visits at month 2 and month 18 for AMD participants; 2 visits total for healthy volunteers
Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, University Hospital Bonn
Bonn, Germany, 53127
Actively Recruiting
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Research Team
M
Maximilian Pfau, MD, FEBO
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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