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

NCT03505567 | Completed FDA Device

• 1 other identifier: RT1-01US
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Retinal Disease; Healthy

Outcome Measures

Primary Outcomes (1)

• Compare KOWA OCT Bi-μ and Optovue iVue 100

  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

  1-2 days

Secondary Outcomes (1)

• Safety: Evaluate any adverse events found during the clinical study

  1-2 days

Study Arms (1)

Random Sequenced Interventions

OTHER

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; Device: Optovue iVue 100

Interventions

KOWA OCT Bi-µ DEVICE

Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.

Random Sequenced Interventions

Optovue iVue 100 DEVICE

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

Random Sequenced Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
• 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:
• 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
• Glaucoma hemi-field test "outside normal limits."
• 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);

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Glaucoma; Retinal Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• David Hosford, MD, Ph.D

  Kowa Research Institute, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible participants assigned two interventions under random sequence assignments.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 23, 2018
• Study Start: April 21, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)