Clinical trial NCT02793206: Spectral Domain OCT Imaging in Patients With Optic Nerve Head Drusen (Tuebingen SD-OCT IN OPTIC NERVE HEAD DRUSEN STUDY)
Official title: Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Disc Drusen
Keywords: Drusen
SD-OCT
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Optic Disc 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in RNFL thickness
timeFrame: baseline and 2 years
Secondary outcomes:
measure: Loss of Visual Fields
timeFrame: baseline and 2 years
measure: Change in auto-fluorescent areas
timeFrame: baseline and 2 years
measure: Change in Drusen material
timeFrame: baseline and 2 years
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Eye Hospital
state: BW
Study officials:
References:
citation: Asensio-Sanchez VM, Trujillo-Guzman L. SD-OCT to distinguish papilledema from pseudopapilledema. Arch Soc Esp Oftalmol. 2015 Oct;90(10):481-3. doi: 10.1016/j.oftal.2015.05.001. Epub 2015 Jul 3. English, Spanish.
citation: Casado A, Rebolleda G, Guerrero L, Leal M, Contreras I, Oblanca N, Munoz-Negrete FJ. Measurement of retinal nerve fiber layer and macular ganglion cell-inner plexiform layer with spectral-domain optical coherence tomography in patients with optic nerve head drusen. Graefes Arch Clin Exp Ophthalmol. 2014 Oct;252(10):1653-60. doi: 10.1007/s00417-014-2773-5. Epub 2014 Aug 17.
citation: Pilat AV, Proudlock FA, Kumar P, Lee H, Papageorgiou E, Gottlob I. Macular morphology in patients with optic nerve head drusen and optic disc edema. Ophthalmology. 2014 Feb;121(2):552-7. doi: 10.1016/j.ophtha.2013.09.037. Epub 2013 Nov 14.
citation: Sato T, Mrejen S, Spaide RF. Multimodal imaging of optic disc drusen. Am J Ophthalmol. 2013 Aug;156(2):275-282.e1. doi: 10.1016/j.ajo.2013.03.039. Epub 2013 May 12.