Advanced Characterization of Autosomal Dominant Optic Atrophy

Optic Atrophy, Autosomal Dominant Clinical Trial

Official title:

Cross Sectional Study of Autosomal Dominant Opticus Atrophy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01522638
• Other study ID #: ADOA
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 30, 2011
• Last updated: January 27, 2012
• Start date: December 2011
• Est. completion date: June 2015

Study information

• Verified date: January 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Subjects diagnosed with autosomal dominant optic atrophy

Exclusion Criteria:

• Age below 8 years old

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atrophy
• Optic Atrophy
• Optic Atrophy, Autosomal Dominant

Locations

Country	Name	City	State
Denmark	Copenhagen University, Glostrup Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity		1 day	No
Primary	vessel caliber		1 day	No
Primary	OCT		1 day	No
Primary	Microperimetry		1 day	No
Primary	Lifestyle questionnaire		1 day	No
Primary	General checkup		1 day	No

External Links

•   Autosomal Dominant Optic Atrophy