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

NCT ID: NCT02793206

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-01

Study Completion Date

2017-05-01

Brief Summary

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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 Description

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Conditions

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Optic Disc Drusen

Keywords

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Drusen SD-OCT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Imaging

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Eye Hospital

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 26148443 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25128962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24238882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23677136 (View on PubMed)

Other Identifiers

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327/2011 BO

Identifier Type: -

Identifier Source: org_study_id