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NCT02793206: TODS

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

Completed Last updated 26 December 2017
What this trial tests

trial testing Imaging in Optic Disc Drusen in 35 participants. Completed in 1 May 2017.

Timeline
1 August 2011
Primary endpoint
1 September 2016
1 May 2017

Quick facts

Lead sponsorUniversity Hospital Tuebingen
StatusCompleted
Study typeOBSERVATIONAL
Enrollment35
Start date1 August 2011
Primary completion1 September 2016
Estimated completion1 May 2017
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Tuebingen

Who can join

Eligibility, any sex, with Optic Disc Drusen. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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