TerminatedNot Applicable

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

Stopped: Study was stopped prior to collection of data from participants due to investigator transfer.

United States42 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 followi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C

Timeframe: Post-Imaging Session (Day 1)

Comfort Level Rating of Device N on 0-5 Scale

Timeframe: Post-Imaging Session (Day 1)

Comfort Level Rating of Device C on 0-5 Scale

Timeframe: Post-Imaging Session (Day 1)

Trial details

NCT IDNCT05686421

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-28

Results submitted2024-10-10

View on ClinicalTrials.gov More Age-Related Macular Degeneration trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C

Timeframe: Post-Imaging Session (Day 1)

Comfort Level Rating of Device N on 0-5 Scale

Timeframe: Post-Imaging Session (Day 1)

Comfort Level Rating of Device C on 0-5 Scale

Timeframe: Post-Imaging Session (Day 1)