Back to resultsNIDEK Gonioscope GS-1 for Glaucoma
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIDEK Gonioscope GS-1
Standard Digital Gonioscopic Images
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with glaucoma or glaucoma suspect
Glaucoma Suspect
- Glaucomatous optic neuropathy as described in the glaucoma patients below
- AND/OR ocular hypertension (IOP > 21 mm Hg)
- Normal visual field
Glaucoma Patients
- Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect
- Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
- Both eyes will be included, except in cases where only one eye meets study criteria
Exclusion Criteria:
- Corneal opacities (scars, edema, etc.)
- Pregnant or planning to become pregnant
- Inability to fixate gaze
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glaucoma & Glaucoma Suspect Patients
Arm Description
Patients with Glaucomatous optic neuropathy
Outcomes
Primary Outcome Measures
Inter-Observer Repeatability for NIDEK Gonioscope GS-1
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
Inter-Observer Repeatability for Standard Digital Gonioscopic images
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03715231
Brief Title
NIDEK Gonioscope GS-1 for Glaucoma
Official Title
NIDEK Gonioscope GS-1 for Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. This study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured images, the glaucoma diagnosis and post-operative observation are enabled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma & Glaucoma Suspect Patients
Arm Type
Experimental
Arm Description
Patients with Glaucomatous optic neuropathy
Intervention Type
Other
Intervention Name(s)
NIDEK Gonioscope GS-1
Intervention Description
To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.
Intervention Type
Other
Intervention Name(s)
Standard Digital Gonioscopic Images
Intervention Description
To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.
Primary Outcome Measure Information:
Title
Inter-Observer Repeatability for NIDEK Gonioscope GS-1
Description
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
Time Frame
1 Day
Title
Inter-Observer Repeatability for Standard Digital Gonioscopic images
Description
To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with glaucoma or glaucoma suspect
Glaucoma Suspect
Glaucomatous optic neuropathy as described in the glaucoma patients below
AND/OR ocular hypertension (IOP > 21 mm Hg)
Normal visual field
Glaucoma Patients
Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect
Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
Both eyes will be included, except in cases where only one eye meets study criteria
Exclusion Criteria:
Corneal opacities (scars, edema, etc.)
Pregnant or planning to become pregnant
Inability to fixate gaze
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Schuman
Organizational Affiliation
NYUMC Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). To achieve aims in the approved proposal.Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Requests should be directed to Zena.Moore@nyulangone.org to gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
NIDEK Gonioscope GS-1 for Glaucoma
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