NCT04319107|Completed
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Sponsor study identifier
observational
110
1 country
1
Study Start
January 1, 2000
Actual (reported)Primary Completion
December 31, 2013
Actual (reported)Study Completion
December 31, 2013
Actual (reported)Marfan syndrome is characterized by musculoskeletal manifestations, cardiovascular disease and ocular abnormalities, particularly ectopia lentis. Diagnosis depends on clinical evaluation, family history and molecular data: mutation in the fibrillin-1 gene (FBN1). Ectopia lentis is the most common ocular manifestation in Marfan syndrome with FBN1 mutation and is relatively specific to this disease when associated with other features. However, clinical examinations for identifying ectopia lentis have not really been codified. The purpose of this study is to describe a 5-grade classification of increasing severity for ectopia lentis based on clinical examination and to evaluate the predictive value for the early grades of ectopia lentis in order to help characterize this major clinical diagnosis criterion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2013
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2000
Actual (reported)December 31, 2013
Actual (reported)December 31, 2013
Actual (reported)March 20, 2020
Actual (reported)March 24, 2020
Actual (reported)Ectopia lentis measurement
Ectopia lentis measurement and classification into 5-stages. Evaluation of the predictive value of ectopia lentis, at early stages, in order to help characterize this major clinical diagnosis criteria.
day 0
Patients who had a clinical diagnosis of MFS according to the revised Ghent criteria (ectopia lentis was not taken into account for the diagnosis), confirmed by FBN1 sequencing.
Relatives of MFS patients with none of the clinical features of MFS and in whom testing for the familial FBN1 mutation was negative.
Pupillary dilatation was performed with instillation of tropicamide and phenylephrine. The ophthalmological examination included visual acuity measurement, using a slit lamp biomicroscopy to analyse the anterior segment and a three mirror lens to appreciate the quality of the dilation validated by the absence of pupillary reflex and to search for ectopia lentis. Ectopia Lentis grade is evaluated according to the 5-grade classification.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MFS patient or Relatives of MFS patients
Hopital Femme Mère Enfant
Bron, France
Zech JC, Putoux A, Decullier E, Fargeton AE, Edery P, Plauchu H, Dupuis-Girod S. Classifying Ectopia Lentis in Marfan Syndrome into Five Grades of Increasing Severity. J Clin Med. 2020 Mar 6;9(3):721. doi: 10.3390/jcm9030721.
Audrey Putoux, MD
Hospices Civils de Lyon
110 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2020
First Posted
March 24, 2020
Study Start
January 1, 2000
Actual (reported)Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2013
Actual (reported)Study Completion
December 31, 2013
Actual (reported)Last Updated
March 27, 2020
Record last verified: 2020-03
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