Age-Related Macular DegenerationNCT05686421
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
A study testing OCT Imaging Using Device N and OCT Imaging Using Device C in people with Age-Related Macular Degeneration and Diabetic Retinopathy, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy
- What is being tested?
- OCT Imaging Using Device N and OCT Imaging Using Device C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
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.
- Conditions
- Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases
- Being tested
- OCT Imaging Using Device N, OCT Imaging Using Device C
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT Imaging Using Device NDevice
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
OCT Imaging Using Device CDevice
Standard conventional OCT imaging device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OCT Imaging Using Device N; Device: OCT Imaging Using Device C |
| 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. Receives: Device: OCT Imaging Using Device N; Device: OCT Imaging Using Device C |
| 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. Receives: Device: OCT Imaging Using Device N; Device: OCT Imaging Using Device C |
| 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. Receives: Device: OCT Imaging Using Device N; Device: OCT Imaging Using Device C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-Imaging Session (Day 1)
Secondary outcomes (2)
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."
Measured: 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."
Measured: Imaging Session (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start30 Mar 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Why it stopped: Study was stopped prior to collection of data from participants due to investigator transfer.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Chaim Gadi Wollstein, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686421
- Sponsor's protocol ID
- 22-01420
- Status last verified
- Oct 2024
- First submitted
- 6 Jan 2023
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
- ClinicalTrials.gov ID
- NCT05686421
- Acronym / sponsor ID
- 22-01420
- Conditions
- Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped prior to collection of data from participants due to investigator transfer.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Device C (OD-OS), then Device N (OD-OS) | Experimental | Device: OCT Imaging Using Device N, Device: OCT Imaging Using Device CParticipants 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 | Device: OCT Imaging Using Device N, Device: OCT Imaging Using Device CParticipants 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 | Device: OCT Imaging Using Device N, Device: OCT Imaging Using Device CParticipants 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 N (OS-OD), then Device C (OS-OD) | Experimental | Device: OCT Imaging Using Device N, Device: OCT Imaging Using Device CParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy volunteers; OR,
- AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye disease
- -- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.
- Healthy Volunteers
- A normal clinical ophthalmic examination.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT Imaging Using Device NStandard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. | Device | 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) |
| OCT Imaging Using Device CStandard conventional OCT imaging device. | Device | 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) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging
Time frame: Imaging Session (Day 1)
Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging
Time frame: Imaging Session (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Gadi Wollstein, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Imaging Using Device N and OCT Imaging Using Device C in people with Age-Related Macular Degeneration and Diabetic Retinopathy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C (time frame: Post-Imaging Session (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.