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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06269666
Other study ID # OPT1100
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2024
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Optos, PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: 1. 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; 2. Subjects who can follow the instructions by the clinical staff at the clinical site; 3. Subjects who agree to participate; 4. 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. Exclusion Criteria: 1. Subjects unable to tolerate ophthalmic imaging; 2. Subjects with ocular media not sufficiently clear to obtain acceptable images.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
P200TxE
SLO and OCT imaging

Locations

Country Name City State
United States Bennett and Bloom Eye Centers Louisville Kentucky

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 1 year
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