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

NCT02793206 | Completed

• 1 other identifier: 327/2011 BO
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Disc Drusen

Keywords

Drusen; SD-OCT

Outcome Measures

Primary Outcomes (1)

• Change in RNFL thickness

  baseline and 2 years

Secondary Outcomes (3)

• Loss of Visual Fields

  baseline and 2 years

• Change in auto-fluorescent areas

  baseline and 2 years

• Change in Drusen material

  baseline and 2 years

Interventions

Imaging DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Optic Disc Drusen

You may qualify if:

• patients with Drusen of the optic disc (as proven by ultrasound and clinical appearance)

You may not qualify if:

• mental disability
• loss of fixation
• other eye diseases potentially leading to a loss of visual fields

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (4)

• 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.

  PMID: 26148443 BACKGROUND

• 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.

  PMID: 25128962 BACKGROUND

• 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.

  PMID: 24238882 BACKGROUND

• 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.

  PMID: 23677136 BACKGROUND

MeSH Terms

Conditions

Optic Disk Drusen

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 8, 2016
• Study Start: August 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 26, 2017

Record last verified: 2016-05

Locations

DE (1)