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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793206
Other study ID # 327/2011 BO
Secondary ID
Status Completed
Phase N/A
First received May 27, 2016
Last updated December 22, 2017
Start date August 1, 2011
Est. completion date May 1, 2017

Study information

Verified date May 2016
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Imaging


Locations

Country Name City State
Germany University Eye Hospital Tuebingen BW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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

Outcome

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