NCT02921568

Brief Summary

This study is designed to evaluate and compare in-tissue performance of OCT scans on the new Optos P200TE, versus the predicate Optos Spectral OCT/SLO device.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below 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

Study Start

First participant enrolled

September 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

March 14, 2017

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 16, 2016

Last Update Submit

March 13, 2017

Conditions

Retinal DiseaseGlaucoma

Outcome Measures

Primary Outcomes (4)

  • retinal thickness

    completion of the study, up to 5 years

  • Retinal Nerve Fibre Layer Thickness

    completion of the study, up to 5 years

  • Optic Nerve Head Topography

    completion of the study, up to 5 years

  • Cup/Disc Ratio

    completion of the study, up to 5 years

Study Arms (1)

All patients

OTHER

All patients will be imaged on the P200TE and Spectral OCT/SLO devices.

Device: P200TEDevice: Spectral OCT/SLO

Interventions

P200TEDEVICE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

All patients
Spectral OCT/SLODEVICE

Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.

All patients

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects 18 years of age or older who have full legal capacity to volunteer;
  • Subjects who have signed the informed consent;
  • Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
  • Subjects who agree to participate in the study;
  • Subjects with current BSCVA 20/400 or better in the ocular disease study eye(s);
  • Subjects diagnosed with ocular disease including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Central Serous Retinopathy, Macular Hole, Epiretinal Membrane, Macular Edema, Glaucoma, and others in the retinal disease study eye(s) as confirmed at the study visit or within the past six (6) months.

You may not qualify if:

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects without ocular disease in study eye(s), as determined by self-report and/or investigator assessment at the study visit;
  • Subjects with history of leukemia, dementia or multiple sclerosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Conditions

Retinal DiseasesGlaucoma

Condition Hierarchy (Ancestors)

Eye DiseasesOcular Hypertension

Study Design

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

Study Record Dates

First Submitted

September 16, 2016

First Posted

October 3, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Last Updated

March 14, 2017

Record last verified: 2016-09

Locations

US(1)