Overview
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.
Description
Age-related macular degeneration (AMD) is a major cause of visual impairment. Treatments currently exist only for late-stage disease, while early and intermediate AMD lack validated functional endpoints suitable for treatment trials. This study will validate fundus-tracked dark adaptometry by determining its diagnostic accuracy, within-visit and between-visit repeatability, and longitudinal sensitivity to change. In addition, multimodal retinal imaging, blood-based biomarkers, metabolomics, proteomics, and AMD-related genetic variants will be assessed for their ability to predict or explain delayed dark adaptation. Healthy volunteers will undergo 2 visits (baseline and month 2); participants with early or intermediate AMD will undergo 3 visits (baseline, month 2, and month 18).
Eligibility
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.
