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NIDEK Gonioscope GS-1 for Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715231
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Glaucoma Diagnostic Test: NIDEK Gonioscope GS-1 Diagnostic Test: Standard Digital Gonioscopic Images Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: NIDEK Gonioscope GS-1 for Glaucoma
Actual Study Start Date : June 12, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Glaucoma & Glaucoma Suspect Patients
Patients with Glaucomatous optic neuropathy
Diagnostic Test: NIDEK Gonioscope GS-1
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.

Diagnostic Test: Standard Digital Gonioscopic Images
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 Measures :
  1. Inter-Observer Repeatability for NIDEK Gonioscope GS-1 [ Time Frame: 1 Day ]
    To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.

  2. Inter-Observer Repeatability for Standard Digital Gonioscopic images [ Time Frame: 1 Day ]
    To determine reliability, two observers will examine images from NIDEK Gonioscopes GS-1. Repeatability will mean observations of both observers will coincide.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03715231


Contacts
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Contact: Tonya Robin 929 455 5041 tonya.robin@nyumc.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Tonya Robin    929-455-5041    tonya.robin@nyumc.org   
Principal Investigator: Joel Schuman, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Joel Schuman NYUMC Langone
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03715231    
Other Study ID Numbers: 18-00429
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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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
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases