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Recruiting

NCT Number: NCT07149740

Data Gathering for A10900

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

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ketchum Health, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion/Exclusion Criteria Inclusion Criteria for Retinal Disease Group

  • 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

Exclusion criteria

for Retinal Disease Group

  • 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;

Inclusion criteria

for Glaucoma Group

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

Exclusion criteria

for Glaucoma Group

  • 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
  • No reliable visual field test result within the previous year from 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 Inclusion Criteria for Corneal Group
  • Participants 22 years of age or older on the date of informed consent 2. Participants able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Participants presenting at the site with corneal disease, for example but not limited to, corneal disorders due to contact lens wear, post-refractive surgery, dry eye, keratoconus 4. Participant is able to comply with the study procedures.

Exclusion criteria

for Corneal Group

  • Participants unable to tolerate ophthalmic imaging
  • 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
  • Participant with ocular media not sufficiently clear to obtain acceptable OCT images.

Inclusion criteria

for Normal Group

  • 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
  • Participants presenting at the site with normal eyes (Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed).
  • BCVA 20/40 or better (each eye)
  • Participant is able to comply with the study procedures

Exclusion criteria

for Normal Group

  • Participants unable to tolerate ophthalmic imaging
  • 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
  • Participant with ocular media not sufficiently clear to obtain acceptable OCT images
  • History of leukemia, dementia or multiple sclerosis

Treatment and study plan

OCT

Device

A10900 is an optical coherence tomography device

Primary outcomes

  1. Number of OCT Scans

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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