Study Comparing the P200TE and the P200TxE in Glaucoma Patients

NCT03912584 | Completed Results FDA Device

• 1 other identifier: OPT1038
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the image quality between two OCT devices.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Qualitative B-Scan Assessment

  Scores will be based on a 4 point grading scale (0 to 3), with 0 corresponding to failure, 1 is poor, 2 is fair, and 3 is good. The four point scale is defined as follows: 0 indicates the scan is a failure, and contains no clinically useful information. No relevant structures are visible in the scan. 1. indicates the condition of the structure or feature being assessed is poor, and it contains very limited clinical utility. 2. indicates the condition of the structure or feature being assessed is fair or average. It contains some useful clinical information and therefore provides adequate clinical utility. 3. indicates the condition of the structure or feature being assessed is good. It contains useful clinical information. The clinical utility is high or good.

  1 day (start: April 29, 2019 - completed: April 30, 2019)

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  1 day

Study Arms (1)

Optical Coherence Tomographer

OTHER

Device: P200TE; Device: P200TxE

Interventions

P200TE DEVICE

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

Optical Coherence Tomographer

P200TxE DEVICE

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

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 who have been diagnosed with glaucoma in the study eye 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 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

Sponsors & Collaborators

• Optos, PLC: lead

Study Sites (1)

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Michael Sinai, PhD
• Organization: Optos

MSinai@optos.com

+1 800 854 3039

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: April 9, 2019
• First Posted: April 11, 2019
• Study Start: April 29, 2019
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 23, 2022
• Results First Posted: September 23, 2022

Record last verified: 2022-09

Locations

US (1)