Study Comparing the P200TE and the P200TxE in Glaucoma Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study evaluates the image quality between two OCT devices.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes

NCT02921568

Retinal Disease Glaucoma

UNKNOWN NA

Study Comparing the P200TxE and P200DTx

NCT03964831

Retinal Disease

COMPLETED NA

Technology-based Eye Care Services (TECS) Compare

NCT02558712

Cataract Macular Degeneration Glaucoma

COMPLETED NA

Data Collection With the P200TE and P200TxE

NCT05615896

Retinal Disease

TERMINATED NA

Adult Providing Access to the Visual Environment (PAVE) - Glaucoma Pilot

NCT00338208

Glaucoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Optical Coherence Tomographer

Group Type OTHER

P200TE

Intervention Type DEVICE

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

P200TxE

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

P200TE

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Intervention Type DEVICE

P200TxE

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion Criteria

* Subjects unable to tolerate ophthalmic imaging;
* Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
* Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
* Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%;
* Subjects with history of dementia or multiple sclerosis

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No