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
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|
|Study Type :||Observational|
|Actual Enrollment :||35 participants|
|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|
- Change in RNFL thickness [ Time Frame: baseline and 2 years ]
- Loss of Visual Fields [ Time Frame: baseline and 2 years ]
- Change in auto-fluorescent areas [ Time Frame: baseline and 2 years ]
- Change in Drusen material [ Time Frame: baseline and 2 years ]
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
|University Eye Hospital|
|Tuebingen, BW, Germany, 72076|