- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061526
Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion
March 1, 2023 updated by: Dr.med. Egbert Matthé, Technische Universität Dresden
Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion - A Pilot Study of Detecting Ischemia in OCT
Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions.
Intracellular edema may develop and decrease transparency of those layers, showing retinal edema.
In spectral domain optical coherence tomography (SD-OCT) retinal reflectivity changes as a result of retinal edema.
The investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions.
Aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades.
In some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion.
State of the art to Diagnose the severity of retinal ischemia is lfuorescein angiography.
However, this technique is invasive and might cause Problems like anaphylactic shock.
Optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion.
The study hope to find criteria by which such a classification can be constructed.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Egbert Matthé, MD
- Phone Number: +493514583381
- Email: egbert.matthe@uniklinikum-dresden.de
Study Contact Backup
- Name: Olga Furashova
Study Locations
-
-
-
Dresden, Germany, 01307
- Recruiting
- University Eye Hospital
-
Contact:
- Egbert Matthé, MD
- Phone Number: +493514583381
- Email: egbert.matthe@uniklinikum-dresden.de
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chart Review of patients treated b/o retinal vessel occlusion, who were examined with optical coherence tomography
Description
Inclusion Criteria:
- acute Retinal vessel occlusion on one eye
- healthy contralateral eye
- examined with spectral Domain optical coherence tomography
Exclusion Criteria:
- retinal occlusion older than 1 week
- OCT Image not obtainable/missing
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: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reflectivity
Time Frame: December 2017
|
optical density of different retinal layers
|
December 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Egbert Matthé, MD, Technical University Dresden
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)
May 1, 2017
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
February 19, 2017
First Submitted That Met QC Criteria
February 19, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
March 1, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 417102016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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