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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital Tuebingen

Current Primary Outcome: Change in RNFL thickness [ Time Frame: baseline and 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University Hospital Tuebingen

Dates:
Date Received: May 27, 2016
Date Started: August 2011
Date Completion: December 2016
Last Updated: June 2, 2016
Last Verified: May 2016