P200TE US Reference Database Study

Normal Eyes Clinical Trial

Official title:

Optos P200TE US Reference Database Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05844852
• Other study ID #: OPT1089
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: May 1, 2024

Study information

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

Clinical Trial Summary

The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

Description:

The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects 22 years of age or older on the date of informed consent

2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent

3. Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.

4. BCVA (best corrected visual acuity) 20/40 or better(each eye)

5. Subject is able to comply with the study procedures

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging

2. 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

3. Subject with ocular media not sufficiently clear toobtain acceptable OCT images

4. .History of leukemia, dementia or multiple sclerosis

Related Conditions & MeSH terms

• Normal Eyes

Intervention

Device:
• P200TE
The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.

Locations

Country	Name	City	State
United States	Marshall B Ketchum University, Southern California College of Optometry	Anaheim	California
United States	Specialty Eye Care Centre	Bellevue	Washington
United States	New England College of Optometry	Boston	Massachusetts
United States	Illinois College of Optometry	Chicago	Illinois
United States	State University of New York, Clinical Vision Research	New York	New York
United States	New England College of Optometry	Roslindale	Massachusetts
United States	Eyecare of San Diego	San Diego	California
United States	Werner Optometry	San Diego	California
United States	Center for Sight	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Optos, PLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal Thickness	The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.	1 year
Primary	GCC Thickness	The GCC Thickness	1 year
Primary	RNFL Thickness	The RNFL thickness	1 year
Primary	Optic Nerve Head	The ONH size	1 year
Secondary	Adverse Events	Number of any adverse events associated with the clinical study to ensure device safety.	1 year