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Advanced Characterization of Autosomal Dominant Optic Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01522638
Recruitment Status : Unknown
Verified January 2012 by Cecilia Rönnbäck, Glostrup University Hospital, Copenhagen.
Recruitment status was:  Enrolling by invitation
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Cecilia Rönnbäck, Glostrup University Hospital, Copenhagen

Tracking Information
First Submitted Date November 30, 2011
First Posted Date January 31, 2012
Last Update Posted Date January 31, 2012
Study Start Date December 2011
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2012)
  • visual acuity [ Time Frame: 1 day ]
  • vessel caliber [ Time Frame: 1 day ]
  • OCT [ Time Frame: 1 day ]
  • Microperimetry [ Time Frame: 1 day ]
  • Lifestyle questionnaire [ Time Frame: 1 day ]
  • General checkup [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Advanced Characterization of Autosomal Dominant Optic Atrophy
Official Title Cross Sectional Study of Autosomal Dominant Opticus Atrophy
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with autosomal dominant optic atrophy in Denmark.
Condition Optic Atrophy, Autosomal Dominant
Intervention Not Provided
Study Groups/Cohorts
  • ADOA
    This group includes subjects diagnosed with autosomal dominant optic atrophy
  • Healthy subjects
Publications * Rönnbäck C, Larsen M. Macular sensitivity and fixation patterns in patients with autosomal dominant optic atrophy. Dan Med J. 2014 Sep;61(9):A4888.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 27, 2012)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

  • Age below 8 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01522638
Other Study ID Numbers ADOA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cecilia Rönnbäck, Glostrup University Hospital, Copenhagen
Study Sponsor Glostrup University Hospital, Copenhagen
Collaborators Not Provided
Investigators
Principal Investigator: Michael Larsen, MD, Prof. DMSc Glostrup University Hospital
PRS Account Glostrup University Hospital, Copenhagen
Verification Date January 2012