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

Primary Purpose

Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT Imaging Using Device N
OCT Imaging Using Device C
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age-Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Comfort Level Rating of Device C 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.

Secondary Outcome Measures

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 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."

Full Information

First Posted
January 6, 2023
Last Updated
May 4, 2023
Sponsor
NYU Langone Health
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT05686421
Brief Title
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
Official Title
A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Eye Institute (NEI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device C (OD-OS), then Device N (OD-OS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Device C (OS-OD), then Device N (OS-OD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Device N (OD-OS), then Device C (OD-OS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Device N (OS-OD), then Device C (OS-OD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OCT Imaging Using Device N
Intervention Description
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.
Intervention Type
Device
Intervention Name(s)
OCT Imaging Using Device C
Intervention Description
Standard conventional OCT imaging device.
Primary Outcome Measure Information:
Title
Percentage of Participants who Indicate Device N Provided a More Comfortable Experience, Compared with Device C
Description
Participants will be asked which device provided a more comfortable experience: Device C or Device N.
Time Frame
Post-Imaging Session (Day 1)
Title
Comfort Level Rating of Device N on 0-5 Scale
Description
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)
Title
Comfort Level Rating of Device C on 0-5 Scale
Description
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)
Secondary Outcome Measure Information:
Title
Time Duration to Adjust for Number of Motion Artifacts Present with Device N Imaging
Description
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)
Title
Time Duration to Adjust for Number of Motion Artifacts Present with Device C Imaging
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaim Gadi Wollstein, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
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.

Learn more about this trial

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

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