NCT02521116

Brief Summary

To date two different instruments are commercially available to measure retinal oxygen saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up to now no data comparing both instruments for the measurement of retinal oxygen saturation and vessel diameter are available in the literature. Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between 2 commercially available systems (DVA, Oxymap T1) Study design: Open pilot study Study population: 30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein occlusion, age 18-80 years Topically administered medication: Tropicamide (Mydriaticum "Agepha"®, Agepha, Vienna, Austria), dose: 1-2 drops per study day for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements of intraocular pressure Nonylacidvanillylamide combined with Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH \& Co KG, Vienna, Austria): topical on the earlobe Methods: Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from earlobe Main outcome variables: Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1 The motive for this investigation is to compare data between 2 commercially available instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in healthy subjects as well as in patients with ocular disease associated with altered retinal oxygenation. Comparative data from both systems are currently not available. Data from this study will allow the comparison of studies performed with different systems. All oxygen measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears to be acceptable.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 3, 2015

Last Update Submit

August 29, 2018

Conditions

Healthy SubjectsDiabetic RetinopathyRetinal Vein Occlusion

Keywords

retinal oxygenationretinal vessel diametersDynamic vessel analyzer (DVA)Oxymap T1

Outcome Measures

Primary Outcomes (1)

  • Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1

    participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days

Secondary Outcomes (1)

  • Difference of retinal vessel diameter between DVA and Oxymap T1

    participants will be followed for the duration of outpatient clinic visit, an expected average of 1 days

Study Arms (1)

Healthy subjects

OTHER

healthy study subjects, age 18-80 years

Other: Dynamic Vessel AnalyzerOther: Oxymap T1

Interventions

Dynamic Vessel AnalyzerOTHER
Healthy subjects
Oxymap T1OTHER
Healthy subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal ophthalmic findings, ametropia \< 3 dpt
  • men and women aged between 18 and 80 years

You may not qualify if:

  • Any of the following will exclude a subject from the study:
  • participation in a clinical trial in the 3 weeks preceding the study
  • symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetic RetinopathyRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and Thrombosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 13, 2015

Study Start

February 1, 2016

Primary Completion

January 3, 2017

Study Completion

February 28, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

AU(1)