Scotopic Microperimetric Assessment of Rod Function in Stargardt Disease (SMART) Study: Design and Baseline Characteristics (Report No. 1).
Clinical trials
Endpoints
Mesopic microperimetry
Scotopic microperimetry
Stargardt disease
Journal
Ophthalmic research
ISSN: 1423-0259
Titre abrégé: Ophthalmic Res
Pays: Switzerland
ID NLM: 0267442
Informations de publication
Date de publication:
2019
2019
Historique:
received:
16
03
2018
accepted:
22
03
2018
pubmed:
26
6
2018
medline:
12
2
2019
entrez:
26
6
2018
Statut:
ppublish
Résumé
To describe the study design and characteristics at first visit of participants in the longitudinal Scotopic Microperimetric Assessment of Rod Function in Stargardt Disease (SMART) study. Scotopic microperimetry (sMP) was performed in one designated study eye in a subset of participants with molecularly proven ABCA4-associated Stargardt disease (STGD1) enrolled in a multicenter natural history study (ProgStar). Study visits were every 6 months over a period ranging from 6 to 24 months, and also included fundus autofluorescence (FAF). SMART enrolled 118 participants (118 eyes). At the first visit of SMART, the mean sensitivity in mesopic microperimetry was 11.48 (±5.05; range 0.00-19.88) dB and in sMP 11.25 (±5.26; 0-19.25) dB. For FAF, all eyes had a lesion of decreased autofluorescence (mean lesion size 3.62 [±3.48; 0.10-21.46] mm2), and a total of 76 eyes (65.5%) had a lesion of definitely decreased autofluorescence with a mean lesion size of 3.46 (±3.60; 0.21-21.46) mm2. Rod function is impaired in STGD1 and can be assessed by sMP. Testing rod function may serve as a potential outcome measure for future clinical treatment trials. This is evaluated in the SMART study.
Identifiants
pubmed: 29940588
pii: 000488711
doi: 10.1159/000488711
pmc: PMC7175756
mid: NIHMS1573836
doi:
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
36-43Subventions
Organisme : NEI NIH HHS
ID : R01 EY009076
Pays : United States
Informations de copyright
© 2018 S. Karger AG, Basel.
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