Study of Retinal Oxygenation in Central Retinal Vein Occl... | NCT02523339

Studies
Study of Retinal Oxygenation in Central Retinal Vein Occlusion

NCT02523339

Sponsor

University of Iceland

Status

Completed

Last Update Posted

Feb 12, 2021Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Retinal Vein Occlusion

Interventions

Not provided

Countries

Austria
Czechia
Denmark
Germany
Iceland
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jun 2018Actual

Completion Date

Nov 3, 2020Actual

First Submitted Date

Aug 7, 2015

First Submission Date that Met QC Criteria

Aug 11, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2021

Last Update Posted Date

Feb 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sveinn Hakon Hardarson, Post-doctoral researcher, University of IcelandPrincipal Investigator

Lead Sponsor

University of IcelandOTHER

Collaborators

Name	Class
University Hospital, Basel, Switzerland	OTHER
Aston University	OTHER
University of Jena	OTHER
Medical University of Vienna

Description Module

Brief Summary

The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal vessel oxygen saturation		12 months
Visual acuity		12 months
Central retinal thickness		12 months
Presence or absence of ocular neovascularisation	As determined by gonioscopic examination	12 months

Secondary Outcomes

Measure	Description	Time Frame
Retinal vessel oxygen saturation		Baseline
Visual acuity		Baseline
Central retinal thickness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected central retinal vein occlusion.
Informed consent for participation.
No treatment before the first oximetry measurement.

Exclusion Criteria:

History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected central retinal vein occlusion (CRVO) will be invited to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sveinn H. Hardarson, PhD	University of Iceland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Pharmacology, Medical University of Vienna		Vienna		1090	Austria
Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided