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Device N (OS-OD), then Device C (OS-OD) for Glaucoma
N/A
Waitlist Available
Led By Chaim Gadi Wollstein, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging session (day 1)
Awards & highlights
Study Summary
This trial will compare two OCT devices to see if one is more comfortable for patients; one has an adjustable chin & forehead rest attached.
Eligible Conditions
- Glaucoma
- Age-Related Macular Degeneration
- Central Serous Retinopathy
- Diabetic Retinopathy
- Eye Diseases
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ imaging session (day 1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging session (day 1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comfort Level Rating of Device C on 0-5 Scale
Comfort Level Rating of Device N on 0-5 Scale
Percentage of Participants who Indicate Device N Provided a More Comfortable Experience, Compared with Device C
Secondary outcome measures
Time Duration to Adjust for Number of Motion Artifacts Present with Device C Imaging
Time Duration to Adjust for Number of Motion Artifacts Present with Device N Imaging
Trial Design
4Treatment groups
Experimental Treatment
Group I: Device N (OS-OD), then Device C (OS-OD)Experimental Treatment2 Interventions
Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device N, a standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional device with no attachment.
Participants will first be imaged using device N starting with the left eye (OS), then right eye (OD). They will then be imaged using device C, starting with OS, then OD.
Group II: Device N (OD-OS), then Device C (OD-OS)Experimental Treatment2 Interventions
Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device N, a standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional device with no attachment.
Participants will first be imaged using device N starting with the right eye (OD), then left eye (OS). They will then be imaged using device C, starting with OD, then OS.
Group III: Device C (OS-OD), then Device N (OS-OD)Experimental Treatment2 Interventions
Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device C, a standard conventional device with no attachment; and device N, the standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device.
Participants will first be imaged using device C starting with the left eye (OS), then right eye (OD). They will then be imaged using device N, starting with OS, then OD.
Group IV: Device C (OD-OS), then Device N (OD-OS)Experimental Treatment2 Interventions
Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device C, a standard conventional device with no attachment; and device N, the standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device.
Participants will first be imaged using device C starting with the right eye (OD), then left eye (OS). They will then be imaged using device N, starting with OD, then OS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCT Imaging Using Device N
2023
N/A
~50
OCT Imaging Using Device C
2023
N/A
~50
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,719 Total Patients Enrolled
7 Trials studying Glaucoma
1,657 Patients Enrolled for Glaucoma
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,886 Total Patients Enrolled
41 Trials studying Glaucoma
13,359 Patients Enrolled for Glaucoma
Chaim Gadi Wollstein, MDPrincipal InvestigatorNYU Langone Health
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity for individuals to participate in this clinical investigation?
"Clinicaltrials.gov indicates that this particular trial is not recruiting participants presently, despite the fact it was posted on January 16th 2023 and updated six days later. Nonetheless, there are 515 other medical studies inviting enrolment currently."
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