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Optos P200TE Agreement and Precision Study

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ClinicalTrials.gov Identifier: NCT03868462
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Optos, PLC

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

Condition or disease Intervention/treatment Phase
Retinal Disease Glaucoma Device: Optos P200TE Device: Predicate Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optos P200TE Agreement and Precision Study
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : September 16, 2019
Actual Study Completion Date : September 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Optical Coherence Tomography (OCT) Device: Optos P200TE
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Device: Predicate 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.




Primary Outcome Measures :
  1. Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm). [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  2. Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm). [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  3. Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm). [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  4. Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio). [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  5. Precision between the Optos P200TE and predicate device measurements of full retinal thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  6. Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  7. Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  8. Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio). [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  9. Precision of the P200TE for the super pixel grid measurements of the full retinal thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  10. Precision of the P200TE for the super pixel grid measurements of the RNFL thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]
  11. Precision of the P200TE for the super pixel grid measurements of GCC thickness. [ Time Frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Normal Group

  1. Subjects 22 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
  4. BCVA 20/40 or better (each eye) on the date of the study visit

    Exclusion Criteria for Normal Group

  5. Subjects unable to tolerate ophthalmic imaging
  6. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
  7. Presence of any ocular pathology except for cataract in either eye
  8. History of leukemia, dementia or multiple sclerosis

    Inclusion Criteria for Glaucoma Group

  9. Subjects 22 years of age or older on the date of informed consent
  10. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  11. BCVA 20/40 or better in the study eye
  12. History of Visual field defects within the previous six (6) months 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."
  13. 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

  14. Subjects unable to tolerate ophthalmic imaging
  15. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
  16. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye
  17. Presence of any ocular pathology except glaucoma in the study eye
  18. History of leukemia, dementia or multiple sclerosis

    Inclusion Criteria for Retina Disease Group

  19. Subjects 22 years of age or older on the date of informed consent
  20. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  21. Subjects presenting at the site with retinal disease
  22. BCVA 20/400 or better in the study eye
  23. Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration (including patients with drusen and geographic atropy and choroidal neovascularization), Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy and others

    Exclusion Criteria for Retinal Disease Group

  24. Subjects unable to tolerate ophthalmic imaging
  25. Subject with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
  26. 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;
  27. History of leukemia, dementia or multiple sclerosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868462


Locations
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United States, Massachusetts
New England Retina Consultants
Springfield, Massachusetts, United States, 01107
Sponsors and Collaborators
Optos, PLC

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Responsible Party: Optos, PLC
ClinicalTrials.gov Identifier: NCT03868462     History of Changes
Other Study ID Numbers: OPT1029
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases