- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05536401
P200TE Agreement and Precision Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60616
- Illinois College of Optometry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Normal Group
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
- BCVA 20/40 or better (each eye) on the date of the study visit
Exclusion Criteria for Normal Group
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- 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
- Presence of any ocular pathology except for cataract in either eye
Inclusion Criteria for Glaucoma Group
- Subjects 22 years of age or older on the date of informed consent
- Subjects 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
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- 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
- No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard or Fast, white on white) result within the past year of 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 Retina Disease Group
- Subjects 22 years of age or older on the date of informed consent
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects presenting at the site with retinal disease
- BCVA 20/400 or better in the study eye
- Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients 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
- Subjects unable to tolerate ophthalmic imaging
- Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
- 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
- Presence of glaucoma or any ocular pathology other than a retinal pathology (e.g., cornea pathology) in the study eye as determined by self-report and/or investigator assessment at the study visit;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Optical Coherence Tomography (OCT)
|
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Time Frame: 1 year
|
1 year
|
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time Frame: 1 year
|
1 year
|
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time Frame: 1 year
|
1 year
|
Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time Frame: 1 year
|
1 year
|
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time Frame: 1 year
|
1 year
|
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Time Frame: 1 year
|
1 year
|
Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time Frame: 1 year
|
1 year
|
Precision between the P200TE and predicate device measurements of full retinal thickness.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPT1060
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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