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P200TE and Predicate Agreement and Precision Study

Primary Purpose

Normal, Retina Disease, Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P200TE
Predicate
Sponsored by
Optos, PLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Normal

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Illinois College of OptometryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Optical Coherence Tomography (OCT)

Arm Description

Outcomes

Primary Outcome Measures

Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
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)
Precision between the P200TE and predicate device measurements of full retinal thickness
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
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)

Secondary Outcome Measures

Full Information

First Posted
November 14, 2022
Last Updated
November 14, 2022
Sponsor
Optos, PLC
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1. Study Identification

Unique Protocol Identification Number
NCT05624593
Brief Title
P200TE and Predicate Agreement and Precision Study
Official Title
P200TE Agreement and Precision Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optos, PLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal, Retina Disease, Glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optical Coherence Tomography (OCT)
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
P200TE
Intervention Description
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Intervention Type
Device
Intervention Name(s)
Predicate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Time Frame
1 year
Title
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time Frame
1 year
Title
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time Frame
1 year
Title
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
Title
Precision between the P200TE and predicate device measurements of full retinal thickness
Time Frame
1 year
Title
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time Frame
1 year
Title
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Time Frame
1 year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eylse Nylin
Phone
312-949-7000
Email
enylin@ico.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Martinez
Phone
312-949-7000
Email
jemartinez@ico.edu
Facility Information:
Facility Name
Illinois College of Optometry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyse Nylin
Phone
312-949-7324
Email
enylin@ico.edu
First Name & Middle Initial & Last Name & Degree
Michael Chaglasian, OD

12. IPD Sharing Statement

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P200TE and Predicate Agreement and Precision Study

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