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Completed

NCT Number: NCT03868462

Optos P200TE Agreement and Precision Study

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.

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Key information

Conditions

Retinal Disease Eye Diseases Glaucoma Ocular Hypertension Retinal Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Who can participate

Healthy volunteers accepted: Yes

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

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 with ocular media not sufficiently clear to obtain acceptable OCT images in either eye
  • Presence of any ocular pathology except for cataract in either eye
  • History of leukemia, dementia or multiple sclerosis

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 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:
  • 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 with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
  • 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
  • Presence of any ocular pathology except glaucoma in the study eye
  • History of leukemia, dementia or multiple sclerosis

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 atropy 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
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye
  • 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;
  • History of leukemia, dementia or multiple sclerosis

Treatment and study plan

Optos P200TE

Device

The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.

Predicate Device

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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Oct 15, 2019

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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