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Spectral Domain OCT Imaging in Patients With Optic Nerve Head Drusen (Tuebingen SD-OCT IN OPTIC NERVE HEAD DRUSEN STUDY) (TODS)

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ClinicalTrials.gov Identifier: NCT02793206
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:

Optic nerve head Drusen are a mostly bilateral change of the optic nerve, eventually causing a slow, but progression loss of the visual fields. Characteristic are the crystalline deposits at the entrance of the optic nerve, the so called optic disc. The material consists of calcium, calcium phosphate, iron, but also amino acids and polysaccharides.

The diagnose is made or confirmed by different imaging modalities like ultrasound and auto-fluorescence imaging. By using the high-resolution imaging with spectral-domain optical coherence imaging (SD-OCT) the volume and deposits at the optic disc can be measured and quantified.

The purpose of this study whether and how defects in the visual fields are related to the deposits. Multimodal imaging of the optic nerve head is planned within the cross-sectional study, at two different time intervals (2 years). Changes in retinal fibre layer (RNFL) thickness and disc parameters are analyzed. Presence and extent of auto-fluorescent changes are evaluated. The prospective trial wants to clarify whether certain parameters at baseline indicate the further outcome and development.


Condition or disease Intervention/treatment
Optic Disc Drusen Device: Imaging

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in RNFL thickness [ Time Frame: baseline and 2 years ]

Secondary Outcome Measures :
  1. Loss of Visual Fields [ Time Frame: baseline and 2 years ]
  2. Change in auto-fluorescent areas [ Time Frame: baseline and 2 years ]
  3. Change in Drusen material [ Time Frame: baseline and 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Optic Disc Drusen
Criteria

Inclusion Criteria:

  • patients with Drusen of the optic disc (as proven by ultrasound and clinical appearance)

Exclusion Criteria:

  • mental disability
  • loss of fixation
  • other eye diseases potentially leading to a loss of visual fields

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793206


Locations
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Germany
University Eye Hospital
Tuebingen, BW, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen

Publications:
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02793206     History of Changes
Other Study ID Numbers: 327/2011 BO
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: May 2016

Keywords provided by University Hospital Tuebingen:
Drusen
SD-OCT

Additional relevant MeSH terms:
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Optic Disk Drusen
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases