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

NCT05686421 | Terminated Results DMC

• 1 other identifier: 22-01420
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (2)

• Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging

  Imaging Session (Day 1)

• Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging

  Imaging Session (Day 1)

Study Arms (4)

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

EXPERIMENTAL

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; Device: OCT Imaging Using Device C

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

EXPERIMENTAL

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; Device: OCT Imaging Using Device C

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

EXPERIMENTAL

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; Device: OCT Imaging Using Device C

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

EXPERIMENTAL

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; Device: OCT Imaging Using Device C

Interventions

OCT Imaging Using Device N DEVICE

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

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)

OCT Imaging Using Device C DEVICE

Standard conventional OCT imaging device.

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Central Serous Chorioretinopathy; Glaucoma; Ocular Hypertension; Eye Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Joel Schuman, MD FACS
• Organization: Wills Eye Hospital

JSchuman@willseye.org

215-928-3197

Study Officials

• Chaim Gadi Wollstein, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: March 30, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)