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

Completed

• Conditions: Optic Disc Drusen

• Registration Number: NCT02793206
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-08
• Primary Completion: 2016-09-01
• Study Completion: 2017-05-01
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in RNFL thickness	baseline and 2 years

Secondary Outcome Measures

Name	Time	Method
Change in auto-fluorescent areas	baseline and 2 years
Change in Drusen material	baseline and 2 years
Loss of Visual Fields	baseline and 2 years

Trial Locations

Locations (1)

University Eye Hospital; 🇩🇪 Tuebingen, BW, Germany