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Study to Compare Kowa OCT Bi-μ and the Optovue iVue 100 (OCT)

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ClinicalTrials.gov Identifier: NCT03505567
Recruitment Status : Completed
First Posted : April 23, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:
This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.

Condition or disease Intervention/treatment Phase
Glaucoma Retinal Disease Healthy Device: KOWA OCT Bi-µ Device: Optovue iVue 100 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Eligible participants assigned two interventions under random sequence assignments.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Comparative Study of the Kowa OCT Bi-μ and the Optovue iVue 100
Actual Study Start Date : April 21, 2018
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Random Sequenced Interventions
Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments.
Device: KOWA OCT Bi-µ
Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.

Device: Optovue iVue 100
U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100




Primary Outcome Measures :
  1. Compare KOWA OCT Bi-μ and Optovue iVue 100 [ Time Frame: 1-2 days ]
    1. Full retinal thickness [Early Treatment Diabetic Retinopathy Study (ETDRS) Grid]
    2. Full retinal thickness (Manual Measurement)
    3. Retinal nerve fiber layer thickness
    4. Ganglion cell complex thickness
    5. Full retinal thickness map


Secondary Outcome Measures :
  1. Safety: Evaluate any adverse events found during the clinical study [ Time Frame: 1-2 days ]
    Evaluate any adverse events found during the clinical study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Normal Group):

  • Subjects with normal eye examinations (without pathology other than cataract) in one or both eyes on the date of the study visit;
  • Subjects with intraocular pressure (IOP) ≤ 21 mmHg in the normal eye(s) on the date of the study visit; and
  • Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in the normal eye(s) on the date the study visit.

Exclusion Criteria (Normal Group):

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects with any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit;
  • Subjects with current narrow anterior chamber drainage angle in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit; and
  • Subjects with a history of leukemia, dementia or multiple sclerosis.

Inclusion Criteria (Glaucoma Group):

  • Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or retinal nerve fiber layer structural abnormalities observed via fundus exam during the study visit:

    1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
    2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue;
  • Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit; and
  • History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage based on at least one of the following 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; and
    2. Glaucoma hemi-field test "outside normal limits."

Exclusion Criteria (Glaucoma Group):

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects with at least one Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard, white on white) measured on the day of the study visit, or within the previous two (2) months from the study visit with unreliable results, defined as fixation losses > 20%, or false positives > 33%, or false negatives > 33% in the glaucoma study eye(s);
  • Subjects with any current ocular pathology except glaucoma in the glaucoma study eye(s), as determined by self-report and/or investigator assessment on the day of the study visit; and
  • Subjects with a history of leukemia, dementia or multiple sclerosis.

Inclusion Criteria (Retinal Disease Group):

  • Subjects with current IOP ≤ 21 mmHg in the retinal disease study eye(s) on the day of the study visit;
  • Subjects with a current BSCVA of 20/400 or better in the retinal disease study eye(s) at the study visit; and
  • Subjects diagnosed with retinal pathology including but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, and others in the retinal disease study eye(s) as confirmed within the past six (6) months.

Exclusion Criteria (Retinal Disease Group):

  • Subjects unable to tolerate ophthalmic imaging;
  • Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
  • Subjects with glaucoma or any ocular pathology other than retinal pathology (e.g. cornea pathology) in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit;
  • Subjects with current narrow anterior chamber drainage angle in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit; and
  • Subjects with a 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): NCT03505567


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Director: David Hosford, MD, Ph.D Kowa Research Institute, Inc.

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03505567     History of Changes
Other Study ID Numbers: RT1-01US
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
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