Actively Recruiting
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
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This monocentric prospective longitudinal observational study will validate fundus-tracked dark adaptometry as an endpoint for future treatment trials in early and intermediate age-related macular degeneration (AMD). The study will characterize normative cone- and rod-mediated dark adaptation parameters in healthy volunteers, assess test-retest reliability, quantify sensitivity to change over time, evaluate diagnostic and prognostic validity against AMD stage and structural progression, and investigate imaging-, biomarker-, and genetics-based determinants of impaired dark adaptation.
CONDITIONS
Official Title
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent.
- All biological sexes and gender identities.
- Age 18 years or older for healthy volunteers; age 55 years or older for participants with AMD.
- Ability to understand German or English sufficiently for study information and procedures.
- Healthy volunteers must have no drusen larger than 63 micrometers and no subretinal drusenoid deposits in either eye.
- Early AMD participants must have study eye with drusen larger than 63 micrometers but less than 125 micrometers and no pigmentary changes.
- Intermediate AMD participants must have 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.
- History of ocular surgery in the study eye 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
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Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, University Hospital Bonn
Bonn, Germany, 53127
Actively Recruiting
Research Team
M
Maximilian Pfau, MD, FEBO
CONTACT
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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