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

Glaucoma Clinical Trial

Official title:

A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686421
• Other study ID #: 22-01420
• Status: Completed
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: April 28, 2023

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Central Serous Chorioretinopathy
• Diabetic Retinopathy
• Eye Diseases
• Glaucoma
• Glaucoma, Suspect
• Macular Degeneration
• Ocular Hypertension

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Post-Imaging Session (Day 1)
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.	Post-Imaging Session (Day 1)
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.	Post-Imaging Session (Day 1)
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."	Imaging Session (Day 1)
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."	Imaging Session (Day 1)