P200TE US Reference Database Study

• Sponsor: Optos, PLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05844852
• Collaborator: (none)
• Enrollment: 800
• Locations: 8
• Arm: 1
• Anticipated Duration (Months): 3.6
• Patients Per Site: 100
• Patients Per Site Per Month: 27.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Normal Eyes	Device: P200TE	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Optos P200TE US Reference Database Study
• Actual Study Start Date: Mar 14, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: OCT Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.	Device: P200TE; The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.

Outcome Measures

Primary Outcome Measures

1. Retinal Thickness [1 year]

   The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.

2. GCC Thickness [1 year]

   The GCC Thickness

3. RNFL Thickness [1 year]

   The RNFL thickness

4. Optic Nerve Head [1 year]

   The ONH size

Secondary Outcome Measures

1. Adverse Events [1 year]

   Number of any adverse events associated with the clinical study to ensure device safety.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marshall B Ketchum University, Southern California College of Optometry	Anaheim	California	United States	92807
2	Werner Optometry	San Diego	California	United States	92019
3	Eyecare of San Diego	San Diego	California	United States	92103
4	Center for Sight	Venice	Florida	United States	34292
5	New England College of Optometry	Boston	Massachusetts	United States	02215
6	New England College of Optometry	Roslindale	Massachusetts	United States	02131
7	State University of New York, Clinical Vision Research	New York	New York	United States	10036
8	Specialty Eye Care Centre	Bellevue	Washington	United States	98004

Sponsors and Collaborators

• Optos, PLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Optos, PLC
• ClinicalTrials.gov Identifier: NCT05844852
• Other Study ID Numbers: OPT1089
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of May 6, 2023