GlaucomaNCT03715231
NIDEK Gonioscope GS-1 for Glaucoma
A study testing NIDEK Gonioscope GS-1 and Standard Digital Gonioscopic Images in people with Glaucoma, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- NIDEK Gonioscope GS-1 and Standard Digital Gonioscopic Images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Corneal opacities (scars, edema, etc.)
- Pregnant or planning to become pregnant
- Inability to fixate gaze
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma
- Being tested
- NIDEK Gonioscope GS-1, Standard Digital Gonioscopic Images
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIDEK Gonioscope GS-1Other
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.
Standard Digital Gonioscopic ImagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma & Glaucoma Suspect Patients | Experimental | Patients with Glaucomatous optic neuropathy Receives: Other: NIDEK Gonioscope GS-1; Other: Standard Digital Gonioscopic Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start12 Jun 2019
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Schuman, Principal investigator, NYUMC Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715231
- Sponsor's protocol ID
- 18-00429
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2018
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36881575
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIDEK Gonioscope GS-1 for Glaucoma
- ClinicalTrials.gov ID
- NCT03715231
- Acronym / sponsor ID
- 18-00429
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma & Glaucoma Suspect Patients | Experimental | Other: NIDEK Gonioscope GS-1, Other: Standard Digital Gonioscopic ImagesPatients with Glaucomatous optic neuropathy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Corneal opacities (scars, edema, etc.)
- Pregnant or planning to become pregnant
- Inability to fixate gaze
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIDEK Gonioscope GS-1To 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. | Other | Glaucoma & Glaucoma Suspect Patients |
| Standard Digital Gonioscopic ImagesTo 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. | Other | Glaucoma & Glaucoma Suspect Patients |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Derived from this study: PubMed 36881575Madu 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Schuman principal investigator
NYUMC Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIDEK Gonioscope GS-1 and Standard Digital Gonioscopic Images in people with Glaucoma, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-Observer Repeatability for NIDEK Gonioscope GS-1 (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03715231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021; AzTrials last refreshed its copy on 5 Nov 2026.