Clinical trial NCT05686421: Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
Official title: A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Age-Related Macular Degeneration
Diabetic Retinopathy
Central Serous Chorioretinopathy
Glaucoma
Glaucoma, Suspect
Eye Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-01-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

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.

Primary outcomes:
measure: Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C
timeFrame: Post-Imaging Session (Day 1)
measure: Comfort Level Rating of Device N on 0-5 Scale
timeFrame: Post-Imaging Session (Day 1)
measure: Comfort Level Rating of Device C on 0-5 Scale
timeFrame: Post-Imaging Session (Day 1)
Secondary outcomes:
measure: Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging
timeFrame: Imaging Session (Day 1)
measure: Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging
timeFrame: Imaging Session (Day 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Chaim Gadi Wollstein, MD
role: PRINCIPAL_INVESTIGATOR
References: