NCT03964831

Brief Summary

The study evaluates image quality between two devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

May 23, 2019

Last Update Submit

September 5, 2024

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (2)

  • Qualitative Image assessment

    Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3).

    6 months

  • Safety Assessment from Adverse Events

    Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.

    6 months

Study Arms (1)

Ultra widefield image capture

OTHER
Device: P200TxEDevice: P200DTx

Interventions

P200TxEDEVICE

The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Ultra widefield image capture
P200DTxDEVICE

The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.

Ultra widefield image capture

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 diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, 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
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

June 18, 2019

Primary Completion

January 14, 2020

Study Completion

January 14, 2020

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)