Glaucoma Evaluation With the P200TE

Glaucoma Clinical Trial

Official title:

Glaucoma Evaluation With the P200TE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305481
• Other study ID #: OPT1099
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Optos, PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Images captured on the P200TE device on glaucoma patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria

Subjects were 22 years of age or older on the date of informed consent;

Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent;

BCVA 20/40 or better in the study eye;

History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:

On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or

Glaucoma hemi-field test "outside normal limits;"

Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and

Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.

Exclusion Criteria

Subjects unable to tolerate ophthalmic imaging;

Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;

Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;

No reliable visual field test result within the past year of the study visit, defined as fixation losses > 33% or false positives >33%, or false negatives >33% in the study eye;

Presence of any ocular pathology except glaucoma in the study eye.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• P200TE
SLO and OCT imaging

Locations

Country	Name	City	State
United States	Specialty Eyecare Centre	Bellevue	Washington
United States	Werner Optometry	Cajon	California

Sponsors (1)

Lead Sponsor	Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of images collected		1 year