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Dark adaptation and Retinal Topography in AMD (DART-AMD)

The impact of structural features on dark adaptation impairment in intermediate age-related macular degeneration: a prospective observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18639700
Enrollment
72
Registered
2025-03-10
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration Eye Diseases

Interventions

The cross-sectional component involves 72 individuals with iAMD. The scotopic MAIA (sMAIA) microperimeter will be controlled with the open perimetry interface (OPI) and a user-friendly app to measure

Sponsors

City, University of London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Intermediate AMD in at least one eye according to the Beckman grading scale (Ferris et al., 2013). The fellow eye can be of any AMD status, including no AMD and late-stage AMD 2. Aged 55-85 years and with the capacity to undertake psychophysical testing (for example, it should have been possible to obtain BCVA in the routine clinical test) 3. Sufficient English language comprehension to enable understanding of the participant information sheet and test instructions 4. ETDRS letter chart BCVA in the study eye not worse than 50 letters (6/30 Snellen VA equivalent)

Exclusion criteria

Exclusion criteria: 1. Ocular pathology in the study eye (or in either eye for genetic conditions), other than age-related macular degeneration, which may affect visual function 2. Van Herick grade 24 mmHg 4. Unable to classify AMD grade or to obtain clear OCT image 5. Lens opacity greater than grade 2 on any LOCS III criterion, or other media opacity/nystagmus that might interfere with quality retinal imaging. 6. Diabetes or other significant systemic disease or medication known to affect visual or retinal function 7. Health condition or other reason to make it unlikely that attendance at the follow-up appointment at 12 months would not be feasible

Design outcomes

Primary

MeasureTime frame
The rate of the second component of rod-mediated dark adaptation (compared between feature-bearing and non-feature-bearing retinal locations) This will be measured at baseline (again within 2 weeks for those participating in the repeatability study) and 12 months. This will be extracted from modelled threshold data from the scotopic MAIA microperimeter and expressed as log units/minute.

Secondary

MeasureTime frame
1. The time constant of cone-mediated dark adaptation. This will be measured at baseline (again within 2 weeks for those participating in the repeatability study), and 12 months. This will be extracted from modelled threshold data from the scotopic MAIA microperimeter, and expressed as minutes. 2. The area under the contrast sensitivity function, measured in log units. This will be measured at baseline (again within 2 weeks for those participating in the repeatability study) and 12 months. The data will be extracted from the PopCSF software (Elfadaly et al. 2020).

Countries

England, United Kingdom

Contacts

Public ContactAlison Binns
Alison.Binns.1@city.ac.uk+44 (0)7939843280

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026