NCT04003831

Brief Summary

The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 12, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

June 12, 2019

Last Update Submit

March 1, 2021

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (2)

  • Qualitative Assessment of OCT Clinical Utility

    Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.

    1 year

  • Qualitative Assessment of OCT Scan Quality

    Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.

    1 year

Secondary Outcomes (1)

  • Safety Assessment from Adverse Events

    1 year

Study Arms (1)

Optical Coherence Tomographer

OTHER
Device: Device: P200TxE

Interventions

Device: P200TxEDEVICE

The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Optical Coherence Tomographer

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
  • Subjects who can follow the instructions by the clinical staff at the clinical site,
  • Subjects who agree to participate in the study;
  • Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.

You may not qualify if:

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Consultants of San Diego

Poway, California, 92064, United States

Location

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

July 1, 2019

Study Start

June 13, 2019

Primary Completion

December 16, 2020

Study Completion

January 18, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)