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NCT Number: NCT06619405

AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance

The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.

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Key information

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

About this study

The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.

The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:

  • Comprehensive eye exam
  • Rod-mediated dark adaptation
  • Reading performance
  • Mobility
  • Ellipsoid zone loss and attenuation

Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Capable and willing to provide consent
  • Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls
  • At least 50 years of age

Exclusion criteria

  • Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading
  • Under 50 years of age
  • Presence of dense cataracts in the study eye (s) that can affect visual function tests
  • Presence of glaucoma requiring treatment during the study and/or visual field defects
  • Previous retinal laser or surgical therapy in the study eye(s)
  • Previous retinal laser or surgical therapy in the study eye(s)
  • Any other ocular condition requiring long-term therapy or surgery during the study
  • The participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing
  • Diagnosis of nystagmus that will interfere with testing
  • High myopia -8 Diopters or more severe
  • The participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.

Treatment and study plan

Streetlab VR

Diagnostic Test

Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.

Primary outcomes

  1. Total number of participants with total ellipsoid zone (EZ) band attenuation

    Time frame: Approximately 2 years

    Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.

Secondary outcomes

  1. Total number of participants with partial ellipsoid zone (EZ) band attenuation

    Time frame: Approximately 2 years

    Partial EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness ≤ 20 μm.

  2. Rod-mediated dark adaptation

    Time frame: Single visit, approximately 5-6 hours

    Measured for right and left eyes separately using the AdaptDx, a computerized dark adaptometer.

  3. Reading performance as measured by the MNREAD (Minnesota low vision reading) chart

    Time frame: Single visit, approximately 5-6 hours

    Reading performance will be assessed binocularly with the MNREAD iPad app on a digital version of the MNREAD chart. The MNREAD is a text based chart used to measure near visual acuity in people with normal or low vision.

  4. Mobility as measured by the Mobility Standardized Test (MOST)

    Time frame: Single visit, approximately 5-6 hours

    The MOST task involves walking through a maze which can be performed under a range of mesopic and photopic conditions. Scoring is automatically computed based on the duration and mobility errors, which generated a score from 0 to 100, with 100 as the best performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Ventura

CONTACT

[email protected]

919-681-6585

Eleonora Lad, MD, PhD

CONTACT

[email protected]

919-684-4359

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Boehringer Ingelheim
  • StreetLab Vision

Registry information

Official study title

AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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