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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* Written informed consent.
* All biological sexes and gender identities.
* Age \>=18 years for healthy volunteers; age \>=55 years for participants with AMD.
* Ability to understand German or English sufficiently for study information and procedures.
Additional Inclusion Criteria by Cohort:
Healthy Volunteers:
\- No drusen \>63 um and no subretinal drusenoid deposits in either eye.
Early AMD:
\- Study eye with drusen \>63 um but \<125 um and no pigmentary changes.
Intermediate AMD:
\- Study eye with drusen \>125 um and/or pigmentary changes.
Exclusion Criteria:
* 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 in the opinion of the investigators.
* Medical conditions or planned operations that could interfere with follow-up.
* Inability to comply with study procedures or insufficient language skills in the study language.
* Inability to provide informed consent.
Primary outcome measure(s)
Rod-Intercept Time — 18 months Change from baseline
Trial sites (1)
Facility
City
Region
Status
Department of Ophthalmology, University Hospital Bonn
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.