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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02793206
Acronym
TODS
Enrollment
35
Registered
2016-06-08
Start date
2011-08-01
Completion date
2017-05-01
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optic Disc Drusen

Keywords

Drusen, SD-OCT

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.

Interventions

DEVICEImaging

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in RNFL thicknessbaseline and 2 years

Secondary

MeasureTime frame
Loss of Visual Fieldsbaseline and 2 years
Change in auto-fluorescent areasbaseline and 2 years
Change in Drusen materialbaseline and 2 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026