Trial Outcomes & Findings for Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations (NCT NCT05686421)
NCT ID: NCT05686421
Last Updated: 2024-11-05
Results Overview
Participants will be asked which device provided a more comfortable experience: Device C or Device N.
TERMINATED
NA
42 participants
Post-Imaging Session (Day 1)
2024-11-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
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|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
20
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Screen failure
|
22
|
0
|
0
|
0
|
Baseline Characteristics
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
Baseline characteristics by cohort
| Measure |
Device C (OD-OS), Then Device N (OD-OS)
n=42 Participants
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.
|
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.
|
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.
|
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.42 years
STANDARD_DEVIATION 18.83 • n=5 Participants
|
—
|
—
|
—
|
60.42 years
STANDARD_DEVIATION 18.83 • n=21 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
—
|
—
|
—
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
—
|
—
|
—
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
—
|
—
|
—
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
—
|
—
|
—
|
25 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
—
|
—
|
—
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
—
|
—
|
—
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
—
|
—
|
—
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
—
|
—
|
—
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
—
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
—
|
—
|
—
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
—
|
—
|
—
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Participants will be asked which device provided a more comfortable experience: Device C or Device N.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Participants will be asked to rate how comfortable Device N was, on a scale of 0-5. Higher scores indicate higher levels of comfort.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
Participants will be asked to rate how comfortable Device C was, on a scale of 0-5. Higher scores indicate higher levels of comfort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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."
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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."
Outcome measures
Outcome data not reported
Adverse Events
Device C (OD-OS), Then Device N (OD-OS)
Device C (OS-OD), Then Device N (OS-OD)
Device N (OD-OS), Then Device C (OD-OS)
Device N (OS-OD), Then Device C (OS-OD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place