Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10017
- NYU Langone Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy volunteers; OR,
- AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye disease
Group-Specific Inclusion Criteria:
-- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.
Healthy Volunteers
- A normal clinical ophthalmic examination.
- Reliable VF, reproducible glaucoma hemifield tests labeled within normal limits on at least one test.
- Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and Ganglion Cell Inner Plexiform Layer (GCIPL) OCT, within normal limits.
Primary Open Angle Glaucoma (POAG)
- Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect.
- Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
- Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with typical glaucomatous RNFL and GCIL thinning.
Normal Tension Glaucoma (NTG)
- Identical to POAG criteria with IOP recorded at ≤ 21 mmHg at any time point.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Device C (OD-OS), then Device N (OD-OS)
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. |
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
Standard conventional OCT imaging device.
|
|
Experimental: Device C (OS-OD), then Device N (OS-OD)
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. |
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
Standard conventional OCT imaging device.
|
|
Experimental: Device N (OD-OS), then Device C (OD-OS)
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. |
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
Standard conventional OCT imaging device.
|
|
Experimental: Device N (OS-OD), then Device C (OS-OD)
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. |
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
Standard conventional OCT imaging device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comfort Level Rating of Device N on 0-5 Scale
Time Frame: Post-Imaging Session (Day 1)
|
Participants will be asked to rate how comfortable Device N was, on a scale of 0-5.
Higher scores indicate higher levels of comfort.
|
Post-Imaging Session (Day 1)
|
|
Comfort Level Rating of Device C on 0-5 Scale
Time Frame: Post-Imaging Session (Day 1)
|
Participants will be asked to rate how comfortable Device C was, on a scale of 0-5.
Higher scores indicate higher levels of comfort.
|
Post-Imaging Session (Day 1)
|
|
Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C
Time Frame: Post-Imaging Session (Day 1)
|
Participants will be asked which device provided a more comfortable experience: Device C or Device N.
|
Post-Imaging Session (Day 1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging
Time Frame: Imaging Session (Day 1)
|
The OCT imaging device includes an "eye tracking" feature that selects a specific location within the eye and constantly adjusts, i.e. tracks, for fine fixation adjustments that occur when a patient's eye is moving very slightly during imaging.
The time to adjust for the number of motion artifacts present will be defined as the duration it takes from the moment the imager clicks "Acquire" on the device to when the progress bar is "Full."
|
Imaging Session (Day 1)
|
|
Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging
Time Frame: Imaging Session (Day 1)
|
The OCT imaging device includes an "eye tracking" feature that selects a specific location within the eye and constantly adjusts, i.e. tracks, for fine fixation adjustments that occur when a patient's eye is moving very slightly during imaging.
The time to adjust for the number of motion artifacts present will be defined as the duration it takes from the moment the imager clicks "Acquire" on the device to when the progress bar is "Full."
|
Imaging Session (Day 1)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chaim Gadi Wollstein, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-01420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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