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Eye Tests of Dark Adaptation in Early and Intermediate Age-Related Macular Degeneration

Studies how well eyes adjust to darkness in people with early macular degeneration.

Plain-language title generated from the registry record
Registry title: Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD

Key facts

Where
Bonn, GermanySee the site

Where in Germany

  • Department of Ophthalmology, University Hospital BonnBonn, GermanyTaking people

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  4. What happens if I want to stop?
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Trial details

Who runs it
Maximilian Pfau
Trial code
NCT07515521
Record updated
7 April 2026
Original description
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.Read full original descriptionShow less

Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD

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.

Inclusion: Written informed consent; All biological sexes and gender identities; Age \&gt;=18 years for healthy volunteers; age \&gt;=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: 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; Hypersensitivity to indocyanine green or sodium iodide, iodine allergy, or hyperthyroidism; Claustrophobia relevant to dark-adaptation procedures; Known pregnancy; Inability to comply with study procedures or insufficient language skills in the study language; Inability to provide informed consent.

ClinicalTrials.gov NCT07515521