NIDEK Gonioscope GS-1 for Glaucoma
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedStudy Start
First participant enrolled
June 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2021
CompletedDecember 30, 2021
December 1, 2021
2 years
October 19, 2018
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
1 Day
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.
1 Day
Study Arms (1)
Glaucoma & Glaucoma Suspect Patients
EXPERIMENTALPatients with Glaucomatous optic neuropathy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Corneal opacities (scars, edema, etc.)
- Pregnant or planning to become pregnant
- Inability to fixate gaze
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Related Publications (1)
Madu CT, Phelps T, Schuman JS, Zambrano R, Lee TF, Panarelli J, Al-Aswad L, Wollstein G. Automated 360-degree goniophotography with the NIDEK Gonioscope GS-1 for glaucoma. PLoS One. 2023 Mar 7;18(3):e0270941. doi: 10.1371/journal.pone.0270941. eCollection 2023.
PMID: 36881575DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Schuman
NYUMC Langone
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2018
First Posted
October 23, 2018
Study Start
June 12, 2019
Primary Completion
May 26, 2021
Study Completion
May 26, 2021
Last Updated
December 30, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 5 years following article publication.
- Access Criteria
- Requests should be directed to Zena.Moore@nyulangone.org to gain access, data requestors will need to sign a data access agreement.
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.