NCT03843840

Brief Summary

The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

May 31, 2018

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Test retest reliability

    Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.

    14 months

Study Arms (1)

Diseased Retina

Device: Combined Coaxial Optical Coherence Tomography

Interventions

Taking images of the retina with two wavelengths

Diseased Retina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with diseased retina

You may qualify if:

  • Age\>18
  • Ability to consent
  • Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
  • clinical care

You may not qualify if:

  • Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
  • the retina and/or choroidal substructures in the opinion of the investigator
  • Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic RetinopathyRetinal DegenerationRetinal Dystrophies

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesEye Diseases, Hereditary

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

February 18, 2019

Study Start

February 15, 2019

Primary Completion

November 30, 2019

Study Completion

October 21, 2020

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations