Purpose

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

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

for Retinal Disease Group 1. 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. BCVA 20/400 or better in the study eye 4. Participants presenting at the site with retinal disease 5. 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 1. Participants unable to tolerate ophthalmic imaging 2. Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons 3. 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 4. 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 1. 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. BCVA 20/40 or better in the study eye 4. 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: 1. 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; 2. Glaucoma hemi-field test "outside normal limits." 5. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: 1. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; 2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue Exclusion Criteria for Glaucoma Group 1. Participants unable to tolerate ophthalmic imaging 2. Participants not able to obtain acceptable OCT images due to ocular media opacity or other reasons 3. 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 4. 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 5. Presence of any ocular pathology except glaucoma in the study eye Inclusion Criteria for Corneal Group 1. 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 1. Participants unable to tolerate ophthalmic imaging 2. 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 3. Participant with ocular media not sufficiently clear to obtain acceptable OCT images. Inclusion Criteria for Normal Group 1. 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 normal eyes (Cataracts, LASIK, PRK, and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed). 4. BCVA 20/40 or better (each eye) 5. Participant is able to comply with the study procedures Exclusion Criteria for Normal Group 1. Participants unable to tolerate ophthalmic imaging 2. 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 3. Participant with ocular media not sufficiently clear to obtain acceptable OCT images 4. History of leukemia, dementia or multiple sclerosis

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Retinal Disease
  • Device: OCT
    A10900 is an optical coherence tomography device
Healthy
  • Device: OCT
    A10900 is an optical coherence tomography device
Glaucoma
  • Device: OCT
    A10900 is an optical coherence tomography device
Corneal Disease
  • Device: OCT
    A10900 is an optical coherence tomography device

Recruiting Locations

Ketchum Health
Anaheim 5323810, California 5332921 92807
Contact:
Sue Parke
714-423-9498
sparker@ketchum.edu

Eye Disease Consultants, LLC
West Hartford 4845411, Connecticut 4831725 06107
Contact:
Matthew Nicholas, MD, PhD
860-549-2020
matthew.nicholas@eyeconsultants.org

Charles Retina Institute
Germantown 4624601, Tennessee 4662168 38138
Contact:
Molly Scott
901-767-4499
mscott@charlesretina.com

More Details

Status
Recruiting
Sponsor
Optos, PLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.