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OpenTrials
Completed

NCT Number: NCT02793206

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging

Device

Primary outcomes

  1. Change in RNFL thickness

    Time frame: baseline and 2 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen

Acronym: TODS

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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