Optic Disc Drusen Clinical Trial
— TODSOfficial title:
Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen
| Verified date | May 2016 |
| Source | University Hospital Tuebingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | May 1, 2017 |
| Est. primary completion date | September 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Eye Hospital | Tuebingen | BW |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen |
Germany,
Asensio-Sánchez VM, Trujillo-Guzmán 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. — View Citation
Casado A, Rebolleda G, Guerrero L, Leal M, Contreras I, Oblanca N, Muñoz-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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in RNFL thickness | baseline and 2 years | ||
| Secondary | Loss of Visual Fields | baseline and 2 years | ||
| Secondary | Change in auto-fluorescent areas | baseline and 2 years | ||
| Secondary | Change in Drusen material | baseline and 2 years |