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Advanced Characterization of Autosomal Dominant Optic Atrophy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cecilia Rönnbäck, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01522638
First received: November 30, 2011
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to determine the anatomy of the retina and the optic nerve in patients with autosomal dominant optic atrophy (ADOA). Based on these findings the aim of the study is to determine why patients with the same type of genetic material, i.e. the same mutation, have such large variations of symptoms, spanning from unaffected subjects to blindness. The project requires examination of both healthy and affected family members.


Condition
Optic Atrophy, Autosomal Dominant

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Cross Sectional Study of Autosomal Dominant Opticus Atrophy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:
  • visual acuity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • vessel caliber [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • OCT [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Microperimetry [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Lifestyle questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • General checkup [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADOA
This group includes subjects diagnosed with autosomal dominant optic atrophy
Healthy subjects

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with autosomal dominant optic atrophy in Denmark.

Criteria

Inclusion Criteria:

  • Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

  • Age below 8 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522638

Locations
Denmark
Copenhagen University, Glostrup Hospital
Copenhagen, Denmark, DK-2600
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Michael Larsen, MD, Prof. DMSc Glostrup University Hospital
  More Information

Additional Information:
Autosomal Dominant Optic Atrophy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Cecilia Rönnbäck, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT01522638     History of Changes
Other Study ID Numbers: ADOA
Study First Received: November 30, 2011
Last Updated: January 27, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Optic Atrophy
Atrophy
Optic Atrophy, Autosomal Dominant
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Pathological Conditions, Anatomical
 Optic Atrophies, Hereditary
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013