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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05686421
Recruitment Status : Not yet recruiting
First Posted : January 17, 2023
Last Update Posted : March 9, 2023
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Diabetic Retinopathy Central Serous Chorioretinopathy Glaucoma Glaucoma, Suspect Eye Diseases Device: OCT Imaging Using Device N Device: OCT Imaging Using Device C Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
Estimated Study Start Date : March 22, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Device: OCT Imaging Using Device N
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

Device: OCT Imaging Using Device C
Standard conventional OCT imaging device.
Experimental: 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.

 Device: OCT Imaging Using Device N
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

Device: OCT Imaging Using Device C
Standard conventional OCT imaging device.
Experimental: 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.

 Device: OCT Imaging Using Device N
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

Device: OCT Imaging Using Device C
Standard conventional OCT imaging device.
Experimental: 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.

 Device: OCT Imaging Using Device N
Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

Device: OCT Imaging Using Device C
Standard conventional OCT imaging device.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 N was, on a scale of 0-5. Higher scores indicate higher levels of comfort.


Secondary Outcome Measures :
  1. Time Duration to Adjust for Number of Motion Artifacts Present with Device N Imaging [ Time Frame: 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."

  2. Time Duration to Adjust for Number of Motion Artifacts Present with Device C Imaging [ Time Frame: 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."


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686421


Contacts
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Contact: Chaim Gadi Wollstein, MD 929-455-5530 Gadi.Wollstein@nyulangone.org
Contact: Joel Schuman, MD 212-263-2939 Joel.Schuman@nyulangone.org

Locations
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United States, New York
NYU Langone Health
New York, New York, United States, 10017
Contact: Chaim Gadi Wollstein, MD    929-455-5530    Gadi.Wollstein@nyulangone.org   
Sponsors and Collaborators
NYU Langone Health
National Eye Institute (NEI)
Investigators
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Principal Investigator: Chaim Gadi Wollstein, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05686421    
Other Study ID Numbers: 22-01420
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Macular Degeneration
Diabetic Retinopathy
Eye Diseases
Central Serous Chorioretinopathy
Ocular Hypertension
Retinal Degeneration
 Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases