Data Gathering for A10900

NCT07149740 | Recruiting FDA Device

• 1 other identifier: OPT1110
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to gather Optical Coherence Tomography (OCT) data on normal and diseased eyes

Conditions

Glaucoma; Corneal Diseases; Retinal Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of OCT Scans

  1 year

Study Arms (4)

Retinal Disease

Device: OCT

Healthy

Device: OCT

Glaucoma

Device: OCT

Corneal Disease

Device: OCT

Interventions

OCT DEVICE

A10900 is an optical coherence tomography device

Corneal Disease; Glaucoma; Healthy; Retinal Disease

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with healthy, glaucoma, retinal disease and corneal disease located in different geographic locations in the US

You may not qualify if:

• Participants 22 years of age or older on the date of informed consent
• Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• BCVA 20/400 or better in the study eye
• Participants presenting at the site with retinal disease
• Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including participants with drusen and geographic atrophy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others
• Participants unable to tolerate ophthalmic imaging
• Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons
• Participant has a condition or is in a situation which the investigator feels may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
• Presence of glaucoma or any ocular pathology other than a retinal pathology in the study eye as determined by self-report and/or investigator assessment at the study visit;
• Participants 22 years of age or older on the date of informed consent
• Participants 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 exists 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;
• Glaucoma hemi-field test "outside normal limits."

Sponsors & Collaborators

• Optos, PLC: lead

Study Sites (4)

Ketchum Health

Anaheim, California, 92807, United States

RECRUITING

Eye Disease Consultants, LLC

West Hartford, Connecticut, 06107, United States

RECRUITING

Eye Care and Laser Surgery of Newton Wellselley

Wellesley Hills, Massachusetts, 02481, United States

COMPLETED

Charles Retina Institute

Germantown, Tennessee, 38138, United States

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Glaucoma; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: September 2, 2025
• Study Start: June 26, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (4)