Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations

Study Overview
=================
Brief Summary
-----------------
In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an 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 OCT device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.

Official Title
-----------------
A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices

Conditions
-----------------
Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases

Intervention / Treatment
-----------------
* Device: OCT Imaging Using Device N
* Device: OCT Imaging Using Device C


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device C (OD-OS), then Device N (OD-OS)<br>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. | Device: OCT Imaging Using Device N<br>* Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.<br>Device: OCT Imaging Using Device C<br>* Standard conventional OCT imaging device.<br>|
| Experimental: Device C (OS-OD), then Device N (OS-OD)<br>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. | Device: OCT Imaging Using Device N<br>* Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.<br>Device: OCT Imaging Using Device C<br>* Standard conventional OCT imaging device.<br>|
| Experimental: Device N (OD-OS), then Device C (OD-OS)<br>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. | Device: OCT Imaging Using Device N<br>* Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.<br>Device: OCT Imaging Using Device C<br>* Standard conventional OCT imaging device.<br>|
| Experimental: Device N (OS-OD), then Device C (OS-OD)<br>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. | Device: OCT Imaging Using Device N<br>* Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.<br>Device: OCT Imaging Using Device C<br>* Standard conventional OCT imaging device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Indicate Device N Provided a More Comfortable Experience, Compared with Device C | Participants will be asked which device provided a more comfortable experience: Device C or Device N. | Post-Imaging Session (Day 1) | 
| Comfort Level Rating of Device N on 0-5 Scale | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Duration to Adjust for Number of Motion Artifacts Present with Device N Imaging | 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 | 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) |