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Study was stopped prior to collection of data from participants due to investigator transfer.
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device C (OD-OS), then Device N (OD-OS) | Experimental | 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 C (OS-OD), then Device N (OS-OD) | Experimental | 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 N (OD-OS), then Device C (OD-OS) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT Imaging Using Device N | Device | Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. |
|
| 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) |
| 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." |
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Inclusion Criteria:
Group-Specific Inclusion Criteria:
-- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.
Healthy Volunteers
Primary Open Angle Glaucoma (POAG)
Normal Tension Glaucoma (NTG)
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.
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| Name | Affiliation | Role |
|---|---|---|
| Chaim Gadi Wollstein, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10017 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Gadi.Wollstein@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access to the data upon reasonable request. Requests should be directed to Gadi.Wollstein@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2023 |
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|
| Device N (OS-OD), then Device C (OS-OD) | Experimental | 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. |
|
| OCT Imaging Using Device C | Device | Standard conventional OCT imaging device. |
|
| 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) |
| FG001 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| FG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| FG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| COMPLETED |
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| NOT COMPLETED |
|
|
No participants were enrolled in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)", or "Device N (OS-OD), then Device C (OS-OD)" arm due to termination of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| BG001 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| BG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| BG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | N=0 participants were analyzed in the "Device C (OD-OS), then Device N (OD-OS)" arm due to early termination of the trial prior to data collection from participants. N=0 participants were analyzed in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)," and "Device N (OS-OD), then Device C (OS-OD)" arms because no participants were enrolled into these arms. | Posted | Post-Imaging Session (Day 1) |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | N=0 participants were analyzed in the "Device C (OD-OS), then Device N (OD-OS)" arm due to early termination of the trial prior to data collection from participants. N=0 participants were analyzed in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)," and "Device N (OS-OD), then Device C (OS-OD)" arms because no participants were enrolled into these arms. | Posted | Post-Imaging Session (Day 1) |
| |||||||||||||||||||||||||||||
| Primary | 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. | N=0 participants were analyzed in the "Device C (OD-OS), then Device N (OD-OS)" arm due to early termination of the trial prior to data collection from participants. N=0 participants were analyzed in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)," and "Device N (OS-OD), then Device C (OS-OD)" arms because no participants were enrolled into these arms. | Posted | Post-Imaging Session (Day 1) |
| |||||||||||||||||||||||||||||
| Secondary | 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." | N=0 participants were analyzed in the "Device C (OD-OS), then Device N (OD-OS)" arm due to early termination of the trial prior to data collection from participants. N=0 participants were analyzed in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)," and "Device N (OS-OD), then Device C (OS-OD)" arms because no participants were enrolled into these arms. | Posted | Imaging Session (Day 1) |
| |||||||||||||||||||||||||||||
| Secondary | 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." | N=0 participants were analyzed in the "Device C (OD-OS), then Device N (OD-OS)" arm due to early termination of the trial prior to data collection from participants. N=0 participants were analyzed in the "Device C (OS-OD), then Device N (OS-OD)", "Device N (OD-OS), then Device C (OD-OS)," and "Device N (OS-OD), then Device C (OS-OD)" arms because no participants were enrolled into these arms. | Posted | Imaging Session (Day 1) |
|
N/A - no participants were assessed for adverse events.
N/A - no participants were assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Schuman, MD FACS | Wills Eye Hospital | 215-928-3197 | JSchuman@willseye.org |
| Oct 10, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2023 | May 4, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D056833 | Central Serous Chorioretinopathy |
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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.
OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
OCT Imaging Using Device C: Standard conventional OCT imaging device.
| OG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
|
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.
OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
OCT Imaging Using Device C: Standard conventional OCT imaging device.
| OG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
|
| OG001 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
|
| OG001 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG002 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
| OG003 | 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. OCT Imaging Using Device N: Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. OCT Imaging Using Device C: Standard conventional OCT imaging device. |
|