NCT04255732

Brief Summary

Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered. Ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown. In Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

January 31, 2020

Last Update Submit

October 3, 2020

Conditions

Keywords

retinal imagingwide field

Outcome Measures

Primary Outcomes (1)

  • difference in retinal periphery viewing between the two devices

    Extent of retinal periphery area viewing (the difference in periphery area between the two devices). Images of the same patients will be compared to determine the degree of periphery viewing for the two devices.

    7 months

Study Arms (1)

Extent of retinal periphery area viewing

OTHER

For the 30 patients fundus photography will be performed using two ultra-wide-field imaging systems.

Device: extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UKDevice: extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany

Interventions

Comparison of the extent of retinal periphery view between two wide field imaging devices.

Extent of retinal periphery area viewing

Comparison of the extent of retinal periphery view between two wide field imaging devices.

Extent of retinal periphery area viewing

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 21 years old
  • Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients
  • Written informed consent prior to any study specific action.

You may not qualify if:

  • Extensive cataract or severe corneal scaring that would affect image quality
  • Fixation problems, nystagmus
  • pregnancy- for women in reproductive age a pregnancy test will be performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Oliver Findl, Prof.

    VIROS, Hanusch Hospital Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Findl, Prof.

CONTACT

Nino Hirnschall, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Ophthalmology Department, principal investigator

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

August 7, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 6, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations