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

December 22, 2017 updated by: University Hospital Tuebingen

Spectral Domain Optic Cohaerence Tomography Imaging in Patients With Optic Nerve Head Drusen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Optic Disc Drusen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in RNFL thickness
Time Frame: baseline and 2 years
baseline and 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Loss of Visual Fields
Time Frame: baseline and 2 years
baseline and 2 years
Change in auto-fluorescent areas
Time Frame: baseline and 2 years
baseline and 2 years
Change in Drusen material
Time Frame: baseline and 2 years
baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 327/2011 BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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