Age-Related Macular Degeneration, Central Serous Chorioretinopathy, Diabetic Retinopathy, Eye Diseases, Glaucoma, Glaucoma, Suspect
Conditions
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.
Interventions
DEVICEOCT Imaging Using Device N
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
DEVICEOCT Imaging Using Device C
Standard conventional OCT imaging device.
Sponsors
National Eye Institute (NEI)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C | Post-Imaging Session (Day 1) | Participants will be asked which device provided a more comfortable experience: Device C or Device N. |
| Comfort Level Rating of Device N on 0-5 Scale | 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. |
| Comfort Level Rating of Device C on 0-5 Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging | 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. |
| Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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 |
| 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 |
| 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 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Screen failure | 22 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Device C (OD-OS), Then Device N (OD-OS) | Total |
|---|---|---|
| Age, Continuous | 60.42 years STANDARD_DEVIATION 18.83 | 60.42 years STANDARD_DEVIATION 18.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 8 Participants |
| Race (NIH/OMB) White | 23 Participants | 23 Participants |
| Region of Enrollment United States | 42 participants | 42 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Post-Imaging Session (Day 1)
Population: 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.
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.
Time frame: Post-Imaging Session (Day 1)
Population: 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.
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.
Time frame: Post-Imaging Session (Day 1)
Population: 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.
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.
Time frame: Imaging Session (Day 1)
Population: 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.
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.
Time frame: Imaging Session (Day 1)
Population: 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.