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OpenTrials
Completed

NCT Number: NCT04201340

Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study

Comparisons for vascular structure visualization in the retina and choroid.

Completed

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Key information

Conditions

Fluorescein Angiography Imaging

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Who can participate

Healthy volunteers accepted: Yes

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

NORMAL GROUP Inclusion Criteria

  • 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 who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
  • Subjects with normal eye exam bilaterally (laser refractive surgery and cataracts are acceptable)
  • IOP ≤ 21 mmHg bilaterally
  • BCVA 20/40 or better bilaterally

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
  • Subjects with known allergy to fluorescein, or subjects having liver disease, or end-stage renal disease
  • Narrow angle
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine or chloroquine
  • Subjects where the study eye was treated after screening and before imaging

RETINAL GROUP Inclusion Criteria

  • 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 who have not participated in the DRI OCT Triton with SS OCT Angio software Evaluation Prestudy
  • BCVA 20/400 or better in the study eye
  • Diagnosis of some type of retinal pathology likely to present in the vasculature in at least one eye as determined by the investigator, may include, but is not limited to: Diabetic retinopathy, Retinal Vein occlusions, Exudative AMD or Macular telangiectasia with expected presentation in the vasculature of, including but not limited to, microaneurysms, capillary dropout and/or choroidal neovascularization.

Exclusion criteria

  • Subjects unable to tolerate ophthalmic imaging
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT-A scans
  • Subjects with known allergy to fluorescein or if ICGA is clinically indicated, indocyanine green dyes, shellfish, iodine, or subjects having liver disease, or end-stage renal disease
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine or chloroquine
  • Subjects where the study eye was treated after screening and before imaging

Treatment and study plan

DRI OCT Triton with SS-OCT Angio software

Device

The Topcon DRI OCT Triton with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes

Cirrus HD-OCT 5000

Device

The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes

TRC-50DX

Device

The TRC-50DX retinal camera images the fundus used for diagnostic purposes

Primary outcomes

  1. Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference

    Time frame: Day 1

    Comparison of OCT devices to TRC-50DX

  2. Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference

    Time frame: Day 1

    Comparison of OCT devices to TRC-50DX

  3. Agreement of pathology identification between the two OCT-A devices

    Time frame: Day 1

    Compare the pathology identifications between the OCT-A devices

Secondary outcomes

  1. OCT-A image quality score (poor, average and good)

    Time frame: Day 1

    Image quality score

Sponsors and collaborators

Lead sponsor

Topcon Corporation

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2019
Registry last updated
Dec 8, 2022

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.