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

NCT ID: NCT05686421

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-04-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

OCT Imaging Using Device N

Intervention Type: DEVICE

Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

OCT Imaging Using Device C

Intervention Type: DEVICE

Standard conventional OCT imaging device.

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.

Group Type: EXPERIMENTAL

OCT Imaging Using Device N

Intervention Type: DEVICE

Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

OCT Imaging Using Device C

Intervention Type: DEVICE

Standard conventional OCT imaging device.

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.

Group Type: EXPERIMENTAL

OCT Imaging Using Device N

Intervention Type: DEVICE

Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

OCT Imaging Using Device C

Intervention Type: DEVICE

Standard conventional OCT imaging device.

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.

Group Type: EXPERIMENTAL

OCT Imaging Using Device N

Intervention Type: DEVICE

Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

OCT Imaging Using Device C

Intervention Type: DEVICE

Standard conventional OCT imaging device.

Interventions

OCT Imaging Using Device N

Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest.

Intervention Type: DEVICE

OCT Imaging Using Device C

Standard conventional OCT imaging device.

Intervention Type: DEVICE

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaim Gadi Wollstein, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

22-01420

Identifier Type: -

Identifier Source: org_study_id