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

NYU Langone Health

Status: Terminated

Conditions: Age-Related Macular Degeneration; Glaucoma; Central Serous Chorioretinopathy; Eye Diseases; Glaucoma, Suspect; Diabetic Retinopathy

Treatments: Device: OCT Imaging Using Device C; Device: OCT Imaging Using Device N

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05686421

22-01420

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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42 participants in 4 patient groups

Device C (OD-OS), then Device N (OD-OS)

Experimental group

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.

Treatment:

Device: OCT Imaging Using Device N

Device: OCT Imaging Using Device C

Device C (OS-OD), then Device N (OS-OD)

Experimental group

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.

Treatment:

Device: OCT Imaging Using Device N

Device: OCT Imaging Using Device C

Device N (OD-OS), then Device C (OD-OS)

Experimental group

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.

Treatment:

Device: OCT Imaging Using Device N

Device: OCT Imaging Using Device C

Device N (OS-OD), then Device C (OS-OD)

Experimental group

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.

Treatment:

Device: OCT Imaging Using Device N

Device: OCT Imaging Using Device C