NCT06269666

Brief Summary

The primary objective is to collect images on the P200TxE device in diseased eyes.

Trial Health

57
Monitor

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 not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 31, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

February 13, 2024

Last Update Submit

September 5, 2024

Conditions

Retinal Disease

Outcome Measures

Primary Outcomes (1)

  • Number of images

    1 year

Study Arms (1)

Imaging Session

OTHER

Various scans will be captured

Device: P200TxE

Interventions

P200TxEDEVICE

SLO and OCT imaging

Imaging Session

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 subject 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;
  • Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.
  • For glaucoma subjects:
  • a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.

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)

Bennett and Bloom Eye Centers

Louisville, Kentucky, 40215, United States

RECRUITING

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

February 13, 2024

First Posted

February 21, 2024

Study Start

January 31, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)