NCT03390205

Brief Summary

In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

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

December 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

December 28, 2017

Last Update Submit

December 28, 2017

Conditions

Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Vessel density

    Vessel density measurements of macula and optic nerve

    5 minutes after intervention ends

Study Arms (2)

Patients

Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation

Controls

Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation

Interventions

Optical coherence tomography angiography under dark and light adaptationDIAGNOSTIC_TEST

Optical coherence tomography angiography under dark and light adaptation with pupil dilatation

ControlsPatients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pathology in vitreo and chorioretinal complex and age matched controls

You may qualify if:

  • Patient with vitreo and chorioretinal pathology, aged-adapted controls

You may not qualify if:

  • Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Adaptation, Ocular

Intervention Hierarchy (Ancestors)

Ocular Physiological Phenomena

Central Study Contacts

Pieter Jan Nelis, MD

CONTACT

0032494354198nelispieter@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

December 28, 2017

First Posted

January 4, 2018

Study Start

February 1, 2018

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

January 4, 2018

Record last verified: 2017-12